SBIR-STTR Award

Enhanced Dexterity Minimally Invasive Surgical Platform
Award last edited on: 9/21/2015

Sponsored Program
SBIR
Awarding Agency
NSF
Total Award Amount
$1,551,608
Award Phase
2
Solicitation Topic Code
-----

Principal Investigator
Shorya Awtar

Company Information

FlexDex LLC (AKA: FlexDex Surgical)

10421 Citation Drive Suite 900
Brighton, MI 48116
   (810) 522-9009
   info@flexdexsurgical.com
   www.flexdexsurgical.com
Location: Single
Congr. District: 08
County: Livingston

Phase I

Contract Number: ----------
Start Date: ----    Completed: ----
Phase I year
2013
Phase I Amount
$180,000
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.

Phase II

Contract Number: ----------
Start Date: ----    Completed: ----
Phase II year
2015
(last award dollars: 2017)
Phase II Amount
$1,371,608

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.