The primary objective of this SBIR is to develop and pre-clinically evaluate a novel lightfield 3D endoscope, dubbed Cerberus-LNR, specially designed for laparoendoscopic single-site surgery (LESS), natural orifice translumenal endoscopic surgery (NOTES), and robotic LESS (R-LESS) (hereafter LNR) procedures. The miniature Cerberus-LNR lightfield 3D endoscope consists of multiple sensors for real-time multiview lightfield 3D image acquisition, an array of LEDs for providing adequate illumination of targets, soft cable for extracorporeal power and video signal connection, and a pair of magnets allowing position/orientation control by a set of reciprocal extracorporeal magnets placed on the external abdominal wall. The Cerberus-LNR is inserted into peritoneal cavity via the single access port, then is navigated to the surgical site and stabilized via extracorporeal magnetic control. It does not occupy the access port after its insertion, leaving the precious asset to othe surgical instruments. The Cerberus-LNR provides unprecedented true 3D image capability for various clinical applications in advanced minimally invasive surgeries (MIS), such as LESS, NOTES and R-LESS: It can (1) Eliminate the "Tunnel vision" and slewed viewing angle problems of existing laparo/endoscopic imaging device by placing a 3D endoscope on the abdominal wall near the surgical site, thus offering a full field of view with proper viewing angl that is not obscured;(2) Spare the over-crowded access port: Traditional laparo/endoscopes occupy precious space in access port preventing or interfering with simultaneous uses of other instruments through the same port, and increase instrument collisions. The proposed Cerberus-LNR uses a thin and soft cable to supply power and transmit video signal, without needing the full occupancy of access port;(3) Maintain correct and stable spatial orientation: Orientations of intraperitoneal images are sometimes sideward or upside down, making it challenging for surgeons to establish a stable horizon and perceive depth during delicate surgical tasks. This can significantly increase surgeons'mental workload and degrade the efficiency and accuracy of LNR procedures. The proposed Cerberus-LNR can use its 3D imaging capability to present images with correct orientation and viewing angle;(4) Offer 3D depth cues: Lightfield 3D images offer surgeons enhanced 3D visual feedback in manipulating, positioning, and operating thereby minimizing risk of complications;(5) Measure the size of surgical targets: Cerberus-LNR can offer quantitative dimensional measurements of objects in the scene, thanks to its unique 3D imaging capability;(6) Perform image guided intervention (IGI): Lightfield 3D images facilitate accurate 3D registration between pre-operative CT/MRI data with in-vivo 3D surface data, thus enabling IGI. (7) Glasses-free 3D display: The lightfield 3D images allow surgeon to visualize 3D target without using any special eyewear. To the best of our knowledge, none of existing 3D endoscopic imaging techniques or products has the capability of capturing a full resolution lightfield image in real-time video stream. At present time, the lack of appropriate instrumentation (especially for optical devices) and lack of significant developmental progress by instrument companies have limited the ability of surgeons to broadly translate the benefits of LNR to patients. New and more effective LNR-specific instrumentation is required clinicians to perform LNR procedures safely and with a shorter learning curve. The proposed Cerberus-LNR fills in the gap and adds one more dimension, literally and figuratively, to existing surgical devices for LESS, NOTES, and R-LESS.
The specific aims for Phase 1 project include:
Aim 1 : Design Cerberus-LNR - 3DCam sensor core;
Aim 2 : Design Cerberus-LNR - Magnetic actuation mechanism;
Aim 3 : Build a functional prototype of the Cerberus-LNR;
Aim 4 : Develop 3D imaging algorithm and software for the Cerberus-LNR;
Aim 5 : Perform extensive phantom model tests;
Aim 6 : Perform pre-clinical evaluation by our clinical team. Full scale commercial product development and extensive clinical evaluations will be performed in the follow-on Phase 2.
Minimally invasive surgeries (MIS) are procedures in which devices are inserted into the body through natural openings or small skin incisions to diagnose and treat/repair a wide range of medical conditions as an alternative to traditional open surgeries. MIS has achieved pre-eminence for many surgery procedures over the last two decades and has led to reduced risk of complications, faster recovery with enhanced patient satisfaction due to reduced postoperative pain and favorable health system economics. To push MIS'boundaries and further reduce morbidity, laparoendoscopic single-site surgery (LESS) technique was developed to minimize the size and number of abdominal ports/ trocars. LESS has been used in cholecystectomy, appendectomy, adrenalectomy, right hemicolectomy, adjustable gastric-band placement, nephrectomy and radical prostatectomy. Compared with conventional laparoscopy, LESS procedures utilize a single access port, and has clear benefits in terms of cosmetics, incremental improvements in postoperative pain, recovery, , and shortened convalescence. Robotic systems such as the da Vinci robotic system have been used for LESS, dubbed R-LESS, to provide easier articulation, motion scaling, and tremor reduction. Natural orifice translumenal endoscopic surgery (NOTES) represents another recent paradigm shift in MIS fields. NOTES are performed with an endoscope passed through a natural orifice (mouth, urethra, anus, etc.) then through an internal incision (in stomach, vagina, bladder or colon) to access the disease site, thus altogether eliminating abdominal incisions/external scars. Human NOTES procedures included diagnostic peritoneoscopy, appendectomy, cholecystectomy, and sleeve gastrectomy. Despite the rapid expansion of these three major MIS advances (LESS, NOTES, and R-LESS, hereafter LNR) over the last few years, lack of proper LNR-specific instruments is the major technical hurdle that prevents a widespread adaptation of these new techniques, thus falling short in translating LNR's tangible benefits to more patients. The operation of LNR requires a single port access to the peritoneal cavity which leads to a raft of broad challenges, ranging from the risk of instruments collisions (i.e., the sword fight) and difficulties in obtaining adequate traction on tissues for dissection, to the reduced triangulation of instruments. The visualization capabilities of existing imaging devices for LNR procedures are problematic and inadequate. All such devices are currently fixed to the single access port site and provide 2D images displayed on a video monitor not in the direct hand-eye axis of the surgeon. Consequently there are significant drawbacks of these existing imaging devices including: 1) Tunnel vision: The field of view (FOV) of laparoscopic images in LNR can be obscured or blocked by surgical devices that pass through the same access port. Images are also in-line with other tools further deteriorating the surgeon's ability to extract D perception of depth from the 2D image. 2) Full-time Occupancy of access port: Traditional laparo/endoscope occupies the precious space in access port all the time, preventing simultaneous uses of other instruments from the same port. 3) Instrument collisions: Occupancy of access port of the laparo/endoscope may cause both internal and external collision with other tools. 4) Skewed viewing angle: placing an endoscope through the solitary port site in LNR procedures can create unfamiliar viewing angles, especially in NOTES . 5) Difficulty in maintaining correct and stable spatial orientation: Orientations of intracorporeal images are sometimes sideward or upside down, making it challenging for surgeons to establish a stable horizon and perceive depth during delicate surgical tasks. This can significantly increase surgeons'mental workload and degrade the efficiency and accuracy of LNR procedures. 6) Lack of 3D imaging capability and depth cues: More importantly, the endoscopes presently used in LNR can only acquire 2D images that lack the third dimension (the depth) information. The primary objective of this SBIR, therefore, is to develop and pre-clinically evaluate a novel lightfield 3D endoscope, dubbed Cerberus-LNR, specially designed for LESS, NOTES, and R-LESS procedures.