SBIR Phase II: Enhanced Dexterity Minimally Invasive Surgical Platform

Period of Performance: 11/19/2014 - 05/31/2017

$705K

Phase 2 SBIR

Recipient Firm

FlexDex LLC
5963 Rollingwood Drive
Ann Arbor, MI 48103
Firm POC, Principal Investigator

Abstract

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is that more patients will benefit from minimally invasive surgery, in which operations are completed through tiny incisions. In addition to patient benefits of less postsurgical pain, less scarring, and quicker recovery, minimally invasive surgery also reduces healthcare cost due to shorter hospital stays and lower risk of post-operative complications. Minimally invasive surgery impacts all surgical specialties, including gynecology, general, bariatric, urologic, and cardiothoracic. Although more than 1.5 million such procedures are performed in the US each year, wider adoption is limited by the high cost of current surgical robots, training burden of traditional hand-held instruments, and complexity of certain minimally invasive procedures. The technology developed via this project will enable surgeons to perform complex minimally invasive procedures such as hysterectomy with minimal training and at a fraction of the cost of surgical robots. Surgeons will benefit from this ergonomic design that will significantly reduce the incidence of workplace related injury associated with many laparoscopic instruments. This development effort will lead to a versatile platform technology that can impact nearly all kinds of surgeries enabling a wider adoption of minimally invasive surgery. The proposed project aims to complete the design, development, verification, validation, regulatory clearance and commercial launch of a laparoscopic articulating needle driver. This novel low-cost minimally invasive surgery technology provides enhanced dexterity and intuitive control that is seen only in multi-million dollar surgical robots. Minimally invasive surgery is performed through small holes on a patient?s body to minimize trauma, blood loss, and recovery time, and generally involves suturing, knot-tying, and fine dissection, all of which would benefit from enhanced dexterity in the surgical instrument. Currently available low-cost mechanical (non-robotic) instruments either lack dexterity or are counter-intuitive to operate, resulting in surgeon fatigue and significant training requirements. Robotic instruments provide exceptional dexterity and intuitive control, but are costly and beyond the reach of many hospitals and patients. The proposal minimally invasive surgery technology platform 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.