Ureteral Stent Electromagnetic Removal USER Device for Pediatric Patients

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43DK115336-01
Agency Tracking Number: R43DK115336
Amount: $224,692.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: 400
Solicitation Number: PA16-302
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-09-01
Award End Date (Contract End Date): 2019-08-31
Small Business Information
3900 ESSEX LN STE 575, Houston, TX, 77027-5175
DUNS: 079612381
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (832) 315-4807
Business Contact
Phone: (713) 579-0073
Email: tiffanie@fannininnovation.com
Research Institution
PROJECT SUMMARY Significance Over children have ureteral stents placed each year to alleviate an obstruction caused by a kidney stone between the kidney and the bladder or to maintain urinary flow following reconstructive or transplant surgery In adults a dangler string that is threaded through the urethra and secured to the skin is simply pulled at a follow up visit to remove the stent but this string is removed in children to prevent infection and accidental removal Children must then undergo an invasive procedure via cystoscopy which consists of inserting a scope into the urethra under general anesthesia to pull the stent out Recent evidence suggests early overexposure to anesthesia has been associated with an increased risk of long term cognitive deficits in language and abstract reasoning As such medical solutions that can provide the same results as traditional procedures without general anesthesia are being sought out in all areas of medicine but particularly in pediatrics Innovation The Ureteral Stent Electromagnetic Removal USER device is a non invasive stent removal system that uses a magnetic bead and an external electromagnet to smoothly guide the stent out of the patientandapos s body without the need for general anesthesia The magnetic bead is coated in a biocompatible material and is secured to the lower stent curl by tying the bead to the dangler string and cutting it short so that the bead and string remain in the patientandapos s bladder The electromagnet is held in a patient friendly casing with smooth surfaces and handles for ease of manipulation This solution shortens the removal process reduces the cost of the procedure and minimizes the risk of cognitive deficits in children from early overexposure to general anesthesia Approach In this SBIR Phase I project Fannin Innovation Studio will optimize the prototype device design and test it in benchtop animal and cadaver models of the urinary tract The Specific Aims of this project are Build and characterize a prototype USER device including magnetic beads and electromagnet with adjustable field strength The performance of various magnet geometries materials and coatings will be characterized and implemented into the prototype The field geometries of the electromagnet will then be evaluated and a user interface to control the magnetic field strength will be built Test the prototype USER device in benchtop animal and cadaver urinary tract models The previous benchtop model will be refined to be more anatomically representative of the pediatric urinary tract with respect to material elasticity and surface characteristics The prototype will then be tested in porcine and cadaver models to assess for signs of tissue damage and further demonstrate the feasibility of the device in living tissue We believe that the USER device will bring value to pediatric patients providers and childrenandapos s hospitals by providing a solution for stent removal that reduces the use of costly OR resources shortens surgeon procedure time and eliminates the risk of cognitive deficits from overexposure to anesthesia in children PROJECT NARRATIVE Ureteral stents are used to relieve obstructions and maintain urinary tract flow following transplant or reconstructive kidney surgery but they must be removed via cystoscopy in children which usually requires general anesthesia Recent evidence indicates that early overexposure to anesthesia in children can lead to long term cognitive deficits and as such medical solutions that are as effective but avoid unnecessary exposure to anesthesia are being sought out in all areas of medicine The USER device utilizes a magnetic bead that is tied to the end of the stent and an external electromagnet to gently pull the stent out through the urethra without the need for cystoscopy or general anesthesia

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

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