3DT HOLDINGS, LLC — Department of Health and Human Services SBIR Phase I: 300

Description

ABSTRACT Defecatory diseases are rapidly growing problems with enormous need for diagnostics and therapeutics An increasing number of patients suffer from defecatory problems and are eligible for diagnostics procedures or therapy Many aspects of the physiology of anorectal function as well as the alterations in the various functional and organic anorectal disorders however are not well understood Despite the easy access to the anorectum only few procedures truly test anorectal function or dysfunction Anorectal physiology tests assess the functioning of the anorectal anatomy A number of tests currently used in the clinic include the balloon expulsion test anorectal manometry defecography dynamic pelvic MRI proctosigmoidoscopy and endoanal ultrasound methods The problem with most of these tests is that they are static and do not mimic the defecation process We have developed prototypes of a new Fecobionics device for mapping geometric and manometric profiles as well as anorectal angle measurements during defecation In this phase I proposal we will integrate the current prototypes into a wireless device The device will make it possible to determine important physiological parameters such as the front and rear pressures and bending of the intraluminal device during defecation without the anorectal function being disturbed by connecting wires or tubes To accomplish the Phase I objectives the safety along with data collection will be assessed in domestic swine in acute and chronic groups This proposal addresses the significant clinical challenges related to diagnosis of functional and organic anorectal disorders Successful completion of the proposed Aims will produce a device that could drastically improve the diagnosis of anorectal disorders The long term goal Phase II is to develop the technology into a device that can be used for biofeedback training by patients in their homes assisted by technicians or nurses remotely to substantially reduce constipation management costs NARRATIVE An increasing number of patients suffer from defecatory problems and are eligible for diagnostics procedures or therapy Many aspects of the physiology of anorectal function as well as the alterations in the broad variety of anorectal disorders are not well understood The overall objective of this proposal is to validate the safety of a novel anorectal expulsion device that determines the geometric and manometric profiles as well as anorectal angle measurements during defecation