This Small Business Innovation Research (SBIR) Phase I project aims to establish the feasibility of a novel minimally invasive surgery (MIS) technology platform that provides enhanced dexterity, intuitive control, and natural force feedback via a low-cost mechanical design. MIS is performed through small holes on a patient?s body to minimize patient trauma, blood loss, and recovery time, and it generally involves suturing, knot-tying, and fine dissection, all of which require enhanced dexterity in the surgical tool. Existing MIS tool technology offers a choice between affordability and functionality. Currently available low-cost mechanical (or non-robotic) tools either lack the necessary dexterity or are counter-intuitive to operate, resulting in surgeon fatigue and significant training requirements. Robotic tools provide exceptional dexterity and intuitive control, but are very expensive and beyond the reach of many healthcare providers and patients. The proposed MIS technology overcomes this affordability versus functionality tradeoff via a novel forearm mounted tool configuration and innovations in parallel-kinematic virtual center mechanisms that makes the tool input joint coincident with the surgeon?s wrist. This results in a natural and intuitive motion transmission from the surgeon?s hand to the tool end-effector via a low-cost design that does not require any sensors, actuators, or computer-control.
The broader impact/commercial potential of this project will be realized by the development and commercialization of the proposed medical device technology will enable surgeons to perform complex MIS procedures such as colectomy and hysterectomy that require suturing, knot-tying and fine dissection with minimal training and at a fraction of the cost of surgical robots. Moreover, the proposed technology can be adapted to any style of end-effector (needle driver, forceps, graspers, scissors, retractor, etc.) and therefore serves as a platform technology for all kinds of surgeries. Given this versatility and reduced cost and training burden, the proposed will enable a wider adoption of MIS, thereby bringing its benefits to a larger portion of the society. In addition to benefits to the patient, MIS also provides healthcare cost-savings due to shorter hospital stays, less postsurgical pain medication, and reduced risk of post-operative complications. Consequently, MIS has impacted several surgical specialties, including bariatric, gastrointestinal, urologic, abdominal, gynecological, and cardiothoracic. Although millions of MIS procedures are performed in the US each year, wider adoption has been limited so far by the high cost of current surgical robots, the training burden of traditional hand-held instruments, and the complexity of certain MIS procedures.
The long-term goal of this project is to develop and commercialize an affordable minimally invasive surgery (MIS) technology platform that provides the level of wrist-like dexterity and intuitive control so far seen only in expensive robotic surgery systems. FlexDex LLC has created this high functionality via a purely mechanical (or non-robotic) tool design, enabled by a novel tool configuration and a parallel-kinematic virtual center mechanism at the tool input. These innovations represent the Intellectual Merit of this work. The resulting technology will broaden the adoption of MIS procedures by dramatically lowering the technology cost as well as surgeon training burden, thus extending the benefits of MIS to a larger portion of the population leading to a Broader Impact. In this Phase 1 project, FlexDex LLC designed, developed and tested pre-clinical prototypes of its proprietary tool technology. These prototypes demonstrated that, during surgical procedures, the FlexDex tool becomes a natural extension of the surgeon’s hand and wrist inside the patient’s body. The technical specifications of the tool were verified via extensive mechanical testing of the prototypes. Furthermore, surgery simulator tests with surgeons from multiple specialties and skill levels validated that the FlexDex tool enables complex MIS tasks such as suturing and knot-tying with considerable ease and minimal training, which is our key value proposition compared to existing laparoscopic products. Having thus established the technical feasibility of the proposed MIS tool concept, FlexDex has started formal product development, verification, and clinical validation, which will be followed by regulatory clearance, manufacturing ramp-up, and first product launch.
