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Award Abstract # 2138136
I-Corps: Novel Intermittent Urinary Catheter Design

NSF Org: TI
Translational Impacts
Recipient: THE ADMINISTRATORS OF TULANE EDUCATIONAL FUND
Initial Amendment Date: July 16, 2021
Latest Amendment Date: January 4, 2023
Award Number: 2138136
Award Instrument: Standard Grant
Program Manager: Jaime A. Camelio
jcamelio@nsf.gov
 (703)292-2061
TI
 Translational Impacts
TIP
 Directorate for Technology, Innovation, and Partnerships
Start Date: July 15, 2021
End Date: December 31, 2023 (Estimated)
Total Intended Award Amount: $50,000.00
Total Awarded Amount to Date: $50,000.00
Funds Obligated to Date: FY 2021 = $50,000.00
History of Investigator:
  • Wayne Hellstrom (Principal Investigator)
    whellst@tulane.edu
  • Cooper Benson (Co-Principal Investigator)
Recipient Sponsored Research Office: Tulane University
6823 SAINT CHARLES AVE
NEW ORLEANS
LA  US  70118-5665
(504)865-4000
Sponsor Congressional District: 01
Primary Place of Performance: Tulane School of Medicine
1430 Tulane Ave
New Orleans
LA  US  70112-2632
Primary Place of Performance
Congressional District:
02
Unique Entity Identifier (UEI): XNY5ULPU8EN6
Parent UEI: XNY5ULPU8EN6
NSF Program(s): I-Corps
Primary Program Source: 01002122DB NSF RESEARCH & RELATED ACTIVIT
Program Reference Code(s): 5345, 9150
Program Element Code(s): 802300
Award Agency Code: 4900
Fund Agency Code: 4900
Assistance Listing Number(s): 47.084

ABSTRACT

The broader impact of this I-Corps project is to reduce the incidence of urinary tract infections (UTIs) caused by intermittent urinary catheter use. The main goal is to reduce morbidity and mortality associated with intermittent urinary catheter use, improve quality of life, and significantly reduce the cost to the health care system. This novel intermittent urinary catheter design offers three important advantages, it : eliminates the translocation of bacteria at the urethral opening into the bladder, prevents catheter contamination due to handling, and eliminates frictional stresses imposed on endothelial tissues during catheter insertion. Together, these features are expected to result in a significant reduction of UTI incidence due to intermittent urinary catheter use.

This I-Corps project develops a novel intermittent urinary catheter with a sheath, initially stored on the inside of the catheter, that is deployed over the catheter as it advances up the urethra, resulting in sterile material covering the catheter that remains stationary against the urethra as the catheter advances. Before deployment, the sterile sheath is inside the catheter with only a small portion on the outside covering the tip connected to a flange. As the catheter is pushed forward, the flange stays in place and a sterile barrier in put between the catheter and the urethra. This technology would eliminate bacteria at the urethral meatus from reaching the bladder and eliminate frictional damage to tissues, in addition to reducing concerns of improper handling.

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 purpose this project was to conduct interviews with critical stakeholders, users, and suppliers of urinary catheters to better understand the market and how to produce the best, most useful and beneficial urinary catheter for the market. We conducted over 100 interviews with patients, physicians, physical/occupational therapists, supplier representatives, manufacturers, and anyone involved in the urinary catheter supply chain and market.

Through these interviews we discovered many pivotal pieces of information for our catheter design and understanding of the innerworkings of the market and supply chain. We learned that, for the patients, the greatest problems with frequent clean intermittent catheterization (CIC) is the pain and discomfort caused by the catheters and the risk for repeated infection. Additionally, many individuals who require CIC to urinate lack dexterity due to spinal cord injury and are thus more likely to have poor clean technique, putting themselves at greater risk for infection.  This helped us to better understand the value of our design that mitigates this issue. Additionally, it may lead to minor design alterations that will allow for easier handling for those with lesser dexterity. The most critical points learned from the manufacturers and suppliers were that hospitals are not an important customer for intermittent catheters because their overall supply was not large enough to be a significant portion of the CIC market. Individuals who have to CIC 4-6 times per day require a much larger supply and are the primary customers for suppliers. We also learned that insurances reimbursements are by type of catheter, therefore, suppliers can push to sell a less expensive catheter for the same reimbursement to increase their margins. This means that patient education is key so that they can advocate for themselves to acquire the catheter that will best suit their needs.

These results have shaped our understanding of how to best get our product to market, how to best navigate it to optimize sales, and emphasize the importance of our design to the patient population for whom it was designed.

The technology that is being developed is a novel urinary catheter design aimed at reducing urinary tract infections caused by catheters, and eliminating pain and tissue damage associated with repeated use. Ultimately this technology will be available to the public for direct purchase in addition to being covered by insurance. 

The greater impact to society is that it will result in reduction of the incidence of UTIs caused by urinary catheters, and thus reduce morbidity and mortality in addition to healthcare system costs with reduction in the burden to the healthcare system.

 


Last Modified: 04/22/2024
Modified by: Wayne J Hellstrom

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