SBIR-STTR Award

Pelvic organ prolapse is a highly prevalent condition affecting at least 50% of women in the US during their lifetimes. Some loss of utero-vaginal support occurs in most adult women, however, the true etiology of prolapse and differences seen among individuals is not entirely understood. Changes in the elasticity of the vaginal walls, connective support tissues and muscles are thought to be significant factors in the development of pelvic organ prolapse. We propose to develop a device entitled Vaginal Tactile Imager (VTI) for visualization and assessment of mechanical properties of pelvic floor tissues. VTI is based on the Tactile Imaging (TI) technology based on principles similar to those of manual palpation. In Phase I we will design and build 1- prototype of VTI with tactile sensor array and a motion tracking sensor. Developed VTI software will support real time data processing and visualization. We plan to fabricate a realistic setup mimicking female pelvic floor for VTI bench validation and operator training. A clinical study with 30 patients will support optimization of the VTI with particular focus on examination procedure, the probe design, tactile data visualization and feature calculation algorithms. The proposed device will quantitatively evaluate multiple mechanical and structural properties of vaginal walls, such as Young's modulus, elasticity contrast, size and shape of abnormal tissue, provide prolapse characterization and assess results of reconstructive surgery.

Public Health Relevance:
Pelvic organ prolapse is a highly prevalent condition affecting at least 50% of women in the US during their lifetimes. Some loss of utero-vaginal support occurs in most adult women. Changes in the elasticity of the vaginal walls, connective support tissues and muscles are thought to be significant factors in the development of pelvic organ prolapse. To date, there is no standardized and non-invasive tool to accurately assess the circumferential elastic properties of the vagina. The goal of this FastTrack project is to develop Vaginal Tactile Imager (VTI) for pelvic floor tissues elasticity imaging and prolapse characterization that could improve pelvic floor disorder diagnosis and treatment. Our preliminary data have shown that VTI has the potential to predict the risk of developing prolapse and provide insight into optimal approaches for surgical repair.

Public Health Relevance Statement:
Project Narrative Pelvic organ prolapse is a highly prevalent condition affecting at least 50% of women in the US during their lifetimes. Some loss of utero-vaginal support occurs in most adult women. Changes in the elasticity of the vaginal walls, connective support tissues and muscles are thought to be significant factors in the development of pelvic organ prolapse. To date, there is no standardized and non-invasive tool to accurately assess the circumferential elastic properties of the vagina. The goal of this FastTrack project is to develop Vaginal Tactile Imager (VTI) for pelvic floor tissues elasticity imaging and prolapse characterization that could improve pelvic floor disorder diagnosis and treatment. Our preliminary data have shown that VTI has the potential to predict the risk of developing prolapse and provide insight into optimal approaches for surgical repair.

Project Terms:
21+ years old; 3-D; 3-Dimensional; Adult; Affect; Algorithms; Biomechanics; Body Tissues; Breast; Cancer Detection; Causality; Clinical Research; Clinical Study; Computer Programs; Computer software; Data; Development; Devices; Diagnosis; Elasticity; Etiology; Female; Genital System, Female, Vagina; Genital System, Male, Prostate; Goals; Grant; Human Prostate; Human Prostate Gland; Human, Adult; Image; Imagery; Imaging Device; Imaging Tool; Imaging technology; Individual; Laboratories; Manuals; Mechanics; Metric; Motion; Muscle; Muscle Tissue; Operation; Operative Procedures; Operative Surgical Procedures; Organ; Palpation; Patients; Pelvic; Pelvic Floor; Pelvic Floor Disorders; Pelvic Region; Pelvic floor structure; Pelvis; Phase; Procedures; Procidentia; Prolapse; Property; Property, LOINC Axis 2; Prostate; Prostate Gland; Prostatic Gland; Ptosis; Quantitative Evaluations; Reconstructive Surgical Procedures; Risk; Shapes; Software; Surgical; Surgical Interventions; Surgical Procedure; Tactile; Testing; Time; Tissues; Training; Vagina; Vaginal; Validation; Visualization; Woman; adult human (21+); base; computer program/software; computerized data processing; data acquisition; data processing; design; designing; disease causation; disease etiology; disease/disorder etiology; disorder etiology; imaging; improved; insight; prototype; public health relevance; reconstructive surgery; repair; repaired; sensor; signal processing; surgery; tool; validation studies

Pelvic organ prolapse is a highly prevalent condition affecting at least 50% of women in the US during their lifetimes. Some loss of utero-vaginal support occurs in most adult women;however, the true etiology of prolapse and differences seen among individuals is not entirely understood. Changes in the elasticity of the vaginal walls, connective support tissues and muscles are thought to be significant factors in the development of pelvic organ prolapse. We propose to develop a device entitled Vaginal Tactile Imager (VTI) for 3-D visualization and assessment of mechanical properties of pelvic floor tissues. VTI is based on the Tactile Imaging (TI) technology based on principles similar to those of manual palpation. In Phase I we designed and build 1- prototype of VTI with tactile sensor array and a motion tracking sensor, tested the training procedure with the phantoms and initiated the clinical development study with 30 patients to optimize the VTI, examination procedure, data processing algorithms and visualization approaches. Clinical results demonstrate applicability of proposed approach for 3-D imaging of the vagina and surrounding structures and characterization of normal and pelvic organ prolapse conditions. In Phase II we plan to build VTI 2-prototype, complete the bench verification studies, EMC and safety testing in the accordance with regulatory compliance to bring the device to clinical validation study with 200 patients, 2 sites, and 5 operators. The proposed device will quantitatively evaluate multiple mechanical and structural properties of vaginal walls, such as elasticity distribution, Young's modulus, elasticity contrast, size and shape of abnormal tissue, provide prolapse characterization and assess results of reconstructive surgery. The completion of proposed project promises to gain scientific knowledge, provide new technical capability and improve clinical practice in gynecology.

Public Health Relevance:
Pelvic organ prolapse is a highly prevalent condition affecting at least 50% of women in the US during their lifetimes. The goal of this project is to develop Vaginal Tactile Imager (VTI) for 3-D elasticity imaging of pelvic floor tissues and prolapse characterization that could improve pelvic floor disorder diagnosis and treatment. Our clinical data have shown that VTI has the potential to predict the risk of developing prolapse and provide insight into optimal approaches for surgical repair.

Thesaurus Terms:
21+ Years Old;3-D;3-D Imaging;3-Dimensional;3d Image;3d Imaging;9-27;Adult;Affect;Algorithms;Architecture;Biomechanics;Body Tissues;Breast Cancer Detection;Breast Cancer Screening;Cd225 Antigen;Causality;Clinical;Clinical Data;Clinical Research;Clinical Study;Computer Programs;Computer Software;Designing Computer Software;Development;Devices;Diagnosis;Documentation;Elasticity;Engineering / Architecture;Etiology;Fragilis Homolog;Genital System, Female, Vagina;Genital System, Male, Prostate;Goals;Grant;Gynecology;History;Human Prostate;Human Prostate Gland;Human, Adult;Ifi17;Ifitm1;Ifitm1 Protein;Ifitm1 Protein, Human;Image;Imagery;Images, 3-D;Imaging Device;Imaging Tool;Imaging Technology;Imaging, Three-Dimensional;Individual;Interferon-Induced Protein 17;Interferon-Induced Transmembrane Protein 1;Interferon-Inducible Protein 9-27;Interferon-Inducible Transmembrane Protein 11;Knowledge;Leu13 Protein, Human;Laboratories;Legal Patent;Manuals;Marketing;Mechanics;Medical Imaging, Three Dimensional;Metric;Motion;Muscle;Muscle Tissue;Nih;National Institutes Of Health;National Institutes Of Health (U.S.);Operation;Operative Procedures;Operative Surgical Procedures;Organ;Outcome;Palpation;Patents;Patients;Pelvic;Pelvic Floor;Pelvic Floor Disorders;Pelvic Region;Pelvic Floor Structure;Pelvis;Phase;Procedures;Procidentia;Prolapse;Property;Property, Loinc Axis 2;Prostate;Prostate Gland;Prostatic Gland;Ptosis;Quantitative Evaluations;Reconstructive Surgical Procedures;Recording Of Previous Events;Reporting;Risk;Safety;Shapes;Site;Software;Software Design;Speed;Speed (Motion);Staging;Structure;Surgical;Surgical Interventions;Surgical Procedure;System;System, Loinc Axis 4;Tactile;Testing;Three-Dimensional Image;Three-Dimensional Imaging;Time;Timeline;Tissues;Training;United States National Institutes Of Health;Vagina;Vaginal;Validation;Visualization;Woman;Adult Human (21+);Base;Clinical Practice;Computer Program /Software;Computer Program/Software;Computerized Data Processing;Data Acquisition;Data Processing;Design;Designing;Disease /Disorder Etiology;Disease Causation;Disease Etiology;Disease/Disorder Etiology;Disorder Etiology;Human Ifitm1 Protein;Imaging;Improved;Insight;Interferon-Induced Transmembrane Protein 1, Human;Mammary Cancer Detection;Multicore Processor;Multiprocessor;Multithreading;Operation;Performance Tests;Prototype;Reconstructive Surgery;Repair;Repaired;Safety Testing;Sensor;Signal Processing;Software Systems;Surgery;Tool;Validation Studies