| NSF Org: |
TI Translational Impacts |
| Recipient: |
|
| Initial Amendment Date: | January 29, 2019 |
| Latest Amendment Date: | April 8, 2019 |
| Award Number: | 1843314 |
| Award Instrument: | Standard Grant |
| Program Manager: |
Henry Ahn
hahn@nsf.gov (703)292-7069 TI Translational Impacts TIP Directorate for Technology, Innovation, and Partnerships |
| Start Date: | February 1, 2019 |
| End Date: | December 31, 2019 (Estimated) |
| Total Intended Award Amount: | $225,000.00 |
| Total Awarded Amount to Date: | $225,000.00 |
| Funds Obligated to Date: |
|
| History of Investigator: |
|
| Recipient Sponsored Research Office: |
700 W RESEARCH CENTER BLVD FAYETTEVILLE AR US 72701-7175 (479)236-2162 |
| Sponsor Congressional District: |
|
| Primary Place of Performance: |
2746 N Hidden Springs Drive FAYETTEVILLE AR US 72703-9203 |
| Primary Place of
Performance Congressional District: |
|
| Unique Entity Identifier (UEI): |
|
| Parent UEI: |
|
| NSF Program(s): | SBIR Phase I |
| Primary Program Source: |
|
| Program Reference Code(s): |
|
| Program Element Code(s): |
|
| Award Agency Code: | 4900 |
| Fund Agency Code: | 4900 |
| Assistance Listing Number(s): | 47.084 |
ABSTRACT
This SBIR Phase I project supports development of an innovative device for use in laparoscopy (minimally invasive surgery of the abdomen). Laparoscopic injuries most often occur during primary port entry, before visualization into the abdominal cavity is possible. Injuries are primarily to the bowel or vasculature and are very serious, with mortality rates up to 5% for bowel injuries and up to 15% for vascular injuries. To minimize this risk, surgeons lift the abdominal wall away from the vital organs that could be inadvertently punctured during primary port entry. Two lifting techniques are commonly utilized, but one is unreliable and the other invasive. The product in development utilizes suction instead of mechanical force to grasp the abdominal wall and is more reliable and less invasive than the current techniques. Projected benefits include better surgical outcomes, increased surgeon and patient satisfaction, and decreased patient post-op pain. Successful development of this product is forecasted to create 40 new jobs by 2023 with an annual payroll exceeding $2.5M. As a direct result of this Phase I grant, this innovative product can reach the U.S. market in 2019 and become the gold standard for abdominal wall lifting devices in the next five years.
The technical innovation in this proposed project is a novel abdominal lifting device for use in laparoscopic surgery that is more reliable and less invasive than current lifting techniques. The novelty of the innovation is affirmed with one issued patent and an additional pending patent application. The device takes advantage of existing suction available in every operating room. This suction allows for the non-invasive attachment of the lifting device to the abdominal wall. Current lifting techniques include manually grasping the abdominal wall and using perforating towel clips. Manual grasp does not always provide a secure grip and perforating towel clips invasively perforate abdominal wall tissue to provide a handle by which to lift and elevate. The technical goals of this project focus on creating a minimum viable product produced with biocompatible materials using standard good manufacturing practices for FDA Class I medical devices. Production quality samples will be produced with five different materials to determine which performs best in terms of strength, reliability, and flexibility. These samples will also be used to determine if any further design changes are needed prior to commercialization.
This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.
PROJECT OUTCOMES REPORT
Disclaimer
This Project Outcomes Report for the General Public is displayed verbatim as submitted by the Principal Investigator (PI) for this award. Any opinions, findings, and conclusions or recommendations expressed in this Report are those of the PI and do not necessarily reflect the views of the National Science Foundation; NSF has not approved or endorsed its content.
The goal of Lapovations' Phase I research was to determine the right manufacturing conditions and materials to produce a minimum viable product (MVP), while qualifying the design, operation, and performance of AbGrab (see image) units produced with an injection mold tooling. AbGrab is an abdominal wall lifting device that uses existing operating room suction to attach to the abdomen and provide a secure handle to lift the abdomen. The Phase I goals were accomplished. The design and performance of the injection mold tool were qualified, and a material was selected for the commercial production of AbGrab. While the Phase I research allowed the successful development and validation of an MVP for commercialization, it also revealed new research opportunities and potential improvements for future versions of AbGrab.
Lapovations' Phase I research comprised a range of challenges involved in developing and manufacturing AbGrab. The technical challenges Lapovations addressed include: 1) testing and selecting a material for AbGrab, 2) qualifying a selected material for AbGrab with production tooling, 3) validating adequate shelf life, 4) gaining feedback from laparoscopic clinicians, and 5) developing standard operating procedures for consistent product quality.
Lapovations was able to achieve the goals of each technical objective in the research plan. Multiple materials were vetted, and a final production material was chosen. Vital production processes have been validated and standard operating procedures and key operating parameters developed. And, most importantly, product development has proceeded, and a minimum viable product was created. This leaves a few final regulatory hurdles before AbGrab can be launched in the U.S., including finalizing labeling content and instructions for use and production transfer. Once these are completed, AbGrab can be registered with the FDA as a Class I device and Lapovations may begin marketing the device to the initial target market. The development of AbGrab provides broad societal benefits of lower surgical risk during laparoscopy, improved patient satisfaction, and a reduction in patient post-op pain.
Last Modified: 01/15/2020
Modified by: Nhiem Cao
Please report errors in award information by writing to: awardsearch@nsf.gov.
