This phase I SBIR application investigates the feasibility of using surgical mesh composed of novel timed-release fibers to controllably contract and provide support to pelvic organs with the long term goal of correcting pelvic floor disorders (PFDs) in elderly women. PFDs including urinary incontinence (UI) affect one in three US women;left untreated they are a major trigger of fractures in the elderly and a primary cause (>50%) of nursing home admissions. The market for surgical kits to treat PFDs is ~$1B/yr and growing as baby boomers age. State-of-the-art treatment uses synthetic mesh or collagen matrixes to augment natural pelvic tissue, enhancing support to the urethrovesicle junction (UVJ, i.e. bladder neck) in UI or genital organs in genital prolapse. However, difficulty in tensioning commercially available surgical mesh presents a barrier to dialing in optimal levels of support. Over-tensioning leads to urethral stenosis, voiding dysfunction, and tissue erosion. To overcome this barrier, Novo Contour proposes biodegradable core-shell fibers to gradually and tunably contract the patient's fascia, providing refined levels of support. The core will be pre-tensioned and secured by the shell so that upon its biodegradation, the mesh scaffold will shrink and lift adjacent tissue. The fiber core and shell are composed of poly(glycerol sebacate) (PGS) and poly(1,3-Bis- (carboxyphenoxy)propane) (PCPP), respectively selected to tunably surface erode over several weeks. The Specific Aims are: (1) To demonstrate feasibility by preparing the first biodegradable, timed-release, and pre- tensioned fibers. The net pre-implant fiber length will be determined as a function of the core's diameter, initial strain, and tensile modulus and shell's diameter. Lift provided by the fibers will be determined as a function of in vitro degradation rate, core diameter, core tensile modulus, initial strain, and applied weight to simulate tissue mass. (2) To evaluate in vivo degradation and contraction rates of core-shell fibers as a function of their dimensions. Fibers will be implanted in New Zealand white rabbits and harvested at intervals out to 4 months. The mesh must sustain organ weight for at least 2-3 months. Novo Contour's SBIR program demonstrates key attributes of these novel biodegradable timed-release core-shell fibers to be integrated as mesh in support kits for minimally invasive pelvic floor surgery, improving surgical safety and efficacy. Their development will change clinical practice by removing the motive for surgeons to initially over tension mesh, decreasing side effects for the patient (e.g. voiding dysfunction &tissue erosion). The proposed research takes advantage of a standing collaboration between the PI, President of Novo Contour, a serial entrepreneur &practicing gynecologist, and Dr. Pease, a Professor of Chemical Engineering and Pharmaceutics &Pharmaceutical Chemistry with experience in polymer fabrication and characterization. The long term objective of Novo Contour is to develop novel surgical techniques to treat PFDs, improving the quality of life for elderly women.
Public Health Relevance: Pelvic floor disorders (PFDs) including urinary incontinence and pelvic organ prolapse adversely affect millions of women leading to embarrassment, incapacitating falls, and nursing home admission. State-of-the- art surgical mesh to surgically treat PFDs abruptly applies tension, tempting the surgeon to over tighten it and increasing surgical complications for patients (e.g. tissue erosion &voiding dysfunction). Novo Contour will fabricate and evaluate innovative pre-tensioned biodegradable core-shell fibers designed to gradually and tunably apply mesh tension to improve surgical outcomes for millions of elderly women.
Thesaurus Terms: Admission;Admission Activity;Adverse Effects;Affect;Age;Aged 65 And Over;Biodegradation;Bladder;Bladder Neck;Bladder Urinary System;Body Tissues;Businesses;Caliber;Chemical Engineering;Collaborations;Collagen;Confined Spaces;Contracting Opportunities;Contracts;Cystocele;Development;Diameter;Dimensions;Domestic Rabbit;Dysfunction;Elderly;Elderly Woman;Enterocele;Environment;Event;Fascia;Fiber;Fracture;Functional Disorder;Genital;Genital Organs;Genital System;Genitalia;Goals;Gynecologist;Harvest;Healed;Human;Implant;In Vitro;Incontinence When Straining;Knowledge;Left;Length;Lifting;Man (Taxonomy);Marketing;Measures;Medicinal Chemistry;Mission;Modern Man;Mucosa;Mucosal Tissue;Mucous Membrane;Nih Program Announcements;New Zealand;Nursing Homes;Operative Procedures;Operative Surgical Procedures;Organ;Organ Weight;Oryctolagus Cuniculus;Out-Patients;Outcome;Outpatients;Pgs Cpd;Parents;Pathologic Constriction;Pathological Constriction;Patients;Pelvic;Pelvic Floor;Pelvic Floor Disorders;Pelvic Region;Pelvic Floor Structure;Pelvis;Pharmaceutic Chemistry;Pharmaceutical Chemistry;Pharmaceutics;Pharmacy (Field);Phase;Physiopathology;Polymers;Position;Positioning Attribute;Procidentia;Proctocele;Program Announcement;Prolapse;Propane;Ptosis;Qol;Quality Of Life;R-Series Research Projects;R01 Mechanism;R01 Program;Rabbits;Rabbits Mammals;Reconstructive Surgical Procedures;Rectocele;Research;Research Grants;Research Project Grants;Research Projects;Sbir;Sbirs (R43/44);Safety;Secure;Simulate;Small Business Innovation Research;Small Business Innovation Research Grant;Stenosis;Stress Incontinence;Stress Urinary Incontinence;Surface;Surgeon;Surgical;Surgical Interventions;Surgical Mesh;Surgical Procedure;Surgical Complication;Techniques;Thick;Thickness;Time;Tissues;Training;Treatment Side Effects;Urethra;Urethral Stenosis;Urethral Stricture;Urinary Incontinence;Urine;Urine Urinary System;Urodynamics;Uterine Prolapse;Vagina;Vaginal;Weight;Woman;Advanced Age;Base;Bone Fracture;Clinical Practice;Design;Designing;Developmental;Elders;Experience;Falls;Flexibility;Flexible;Geriatric;Healing;Improved;In Vivo;Innovate;Innovation;Innovative;Late Life;Later Life;Minimally Invasive;Novel;Nursing Home;Older Adult;Older Person;Over 65 Elderly;Pathophysiology;Poly(Glycerol-Sebacate);Preclinical Evaluation;Professor;Programs;Reconstructive Surgery;Repair;Repaired;Scaffold;Scaffolding;Senior Citizen;Side Effect;Success;Surgery;Therapy Adverse Effect;Treatment Adverse Effect;Urethra Stricture;Urethral;Urinary Bladder;Urinary Bladder Neck;Urogenital System (Genital Part);Uterus Prolapse
