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A Laparoscopic Grasping Instrument for Robust and Atraumatic Tissue Manipulation in Minimally-Invasive Gastrointestinal Surgery

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43AG066230-01A1
Agency Tracking Number: R43AG066230
Amount: $224,952.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: R
Solicitation Number: PA19-272
Timeline
Solicitation Year: 2019
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-05-15
Award End Date (Contract End Date): 2020-10-31
Small Business Information
101 MISSISSIPPI STREET
San Francisco, CA 94107-2523
United States
DUNS: 621187249
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 MICHAEL JAASMA
 (510) 220-2699
 mjaasma@theranova.com
Business Contact
 ELINOR BANAI
Phone: (202) 823-9639
Email: ebanai@theranova.com
Research Institution
N/A
Abstract

Abstract
With up to 4.8 million procedures annually in the U.S., laparoscopy has rapidly become the surgical standard for
a wide range of procedures. Compared to open procedures, laparoscopic approaches reduce muscle damage,
blood loss, post-operative pain, complication rates, and length of hospital stay. However, laparoscopy has unique
technique-specific limitations and complications, so the perception that minimally invasive surgery is minimally
traumatic is imprecise. There is now evidence that the frail, aging population may benefit most from laparoscopic
techniques. Thus, advances in laparoscopic techniques that reduce surgery-related complications would provide
important benefits to the older patient population. Although laparoscopy has generally improved surgical
outcomes, current instruments can contribute to procedure-related complications. To grasp and manipulate
tissue, surgeons typically use the compressive grasper, a tool that pinches tissue between the teeth of two jaws.
While compressive graspers are well-suited for grasping smaller structures, the typical V-shaped jaws only open
to a maximum of 3.5-10 mm apart, so they are not optimized for grasping larger structures, particularly stiff
structures like the inflamed gallbladder. As a result of the compressive grasper’s design, excessive grasping and
retraction forces, long duration of grasps, and slippage of the tissue in the grasper jaws can all contribute to
tissue injury and perforation. In turn, intraoperative tissue damage can lengthen operative time, result in
conversion to traditional open surgery, and increase patient morbidity. In addition to immediately apparent
damage, tissue injury during surgery can result in delayed perforations and significant patient morbidity.
Therefore, the risk of iatrogenic tissue injury is a central and ubiquitous concern for surgeons. To address the
need for a laparoscopic grasper capable of gripping a broad array of tissue types without the risk of slippage or
iatrogenic injury, TheraNova is developing the Lamprey Grasper, a novel, atraumatic laparoscopic grasper. Our
goal is to improve key functionalities within the grasper family, particularly in grasping larger, stiffer structures.
In preliminary studies, we demonstrated that several Lamprey Grasper designs enable a strong, reliable tissue
grasp while inducing less injury than a compressive grasper. The overall goals of this proposal are to build on
this promising work to optimize and validate the Lamprey Grasper. In Specific Aim 1, we will conduct a benchtop
evaluation to identify the optimal Lamprey Grasper design for robust grasping across a range of porcine
abdominal tissues. In Specific Aim 1, we will use the optimal design from Aim 1 to conduct a comprehensive in
vivo evaluation of the Lamprey Grasper vs. a conventional compressive grasper. Two experienced laparoscopic
surgeons will perform a series of laparoscopic actions in Yorkshire pigs (n=6) to compare functionality, usability,
and grasper-induced tissue injury between the two graspers. If this Phase I work is successful, in Phase II we
will conduct a large, post-operative survival animal study to validate the functionality, usability, and safety of the
Lamprey Grasper, which will support a 510(k) submission to the FDA.Narrative
Laparoscopy has generally improved surgical outcomes for appropriately selected patients, but current
laparoscopic tissue graspers can contribute to procedure-related complications through grasping-inducing tissue
injury or perforation. There is now evidence that the frail, aging population may benefit most from laparoscopic
procedures, so advances in laparoscopic surgery that reduce complications would provide important benefits to
the older patient population. In this SBIR Phase I, we propose to optimize a novel laparoscopic instrument
capable of grasping a broad array of tissue types without the risk of slippage or traumatic injury.

* Information listed above is at the time of submission. *

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