SBIR-STTR Award

We propose a new interventional device that solves a significant therapeutic bottleneck in the treatment of lens cataract in children. As the leading cause of childhood blindness, lens cataract interferes with the optical performance of the eye and if untreated, results in lifelong deficits in visual perception. The first step in pediatric cataract surgery is technically the most challenging and involves the creation of a hole in the thin and highly elastic lens capsule to provide access for the subsequent removal of the diseased lens and if needed, the implantation of an artificial lens. Due to the unique biomechanical properties of the immature lens capsule, adult procedures for creating the capsulotomy opening, if applied to infants and young children, only have a 20% chance of success. Capsule tears hinder lens removal and affect the mechanical stability and performance of artificial lens implants. Currently, pediatric cataract surgeons must make do using devices with tissue chopping functions originally designed for non-cataract surgical uses, resulting in suboptimal pediatric lens capsulotomies. In order to simplify and automate pediatric lens capsulotomies and thus enhance the delivery of vision care to young patients, we propose a micro and nanotechnology-enhanced capsulotomy device to achieve consistent results across a range of surgical skills. The device is based on a proprietary method of tissue cutting in which a microfabricated cutting ring is housed within a collapsible elastomeric housing to produce precise capsulotomies on a microsecond time scale. Our device is inserted through the standard 2.75 mm corneal incision and re-expands to produce a desired capsulotomy of 5.5 mm in diameter. In preliminary work, we have obtained proof of principle for important device functions including capsule cutting and device compressibility. In the proposed studies, we will optimize device component designs, choice of materials, and conduct engineering stress tests. Device function will also be tested using both ex vivo eye models and in a small surgical series in rabbits whose lens capsule mimics the elastic capsule of the pediatric lens. The goal of this Phase I study is the production and functional validation of an automated lens capsulotomy device suitable for extensive device safety and performance trials in Phase II.

Public Health Relevance:
This work seeks to develop a microtechnology and nanotechnology-enhanced surgical instrument to aid in the treatment of childhood blindness due to lens cataract. Lens cataract is the leading cause of pediatric visual disabilities, and cataract removal restores sight and improves the quality of life for both patients and their families. The proposed device simplifies and automates a technically challenging surgical task in cataract surgery.

Thesaurus Terms:
0-11 Years Old;21+ Years Old;Abscission;Accounting;Address;Adult;Affect;Anterior;Anterior Chamber;Anterior Chamber Of The Eye;Anterior Chamber Of Eye Structure;Artificial Lens, Device;Biomechanics;Blindness;Body Tissues;Caps;Caliber;Capsules;Caring;Cataract;Cataract Extraction;Child;Child Youth;Childhood;Children (0-21);Clinical Evaluation;Clinical Testing;Clinical Effectiveness;Cornea;Defect;Development;Device Designs;Device Safety;Devices;Diameter;Disease;Disorder;Elastomers;Engineering;Engineerings;Equipment;Excision;Extirpation;Eye;Eyeball;Family;Goals;Harvest;Health Care Costs;Health Costs;Healthcare Costs;Housing;Human;Human, Adult;Human, Child;Human, General;Implant;Infant;Intervention;Intervention Strategies;Intraocular Lens Implant Device;Lens Capsule;Lenses, Intraocular;Mammals, Rabbits;Man (Taxonomy);Man, Modern;Manuals;Mechanics;Medical Technology;Membrane;Methods;Metric;Modeling;Nanoscale Science;Nanotechnology;Only Child;Operation;Operative Procedures;Operative Surgical Procedures;Ophthalmology;Optics;Oryctolagus Cuniculus;Ostamer;Otomy;Pathology;Patients;Pellethane;Performance;Phase;Polyisocyanates;Polyurethanes;Population;Procedures;Process;Production;Property;Property, Loinc Axis 2;Qol;Quality Of Life;Rabbit, Domestic;Rabbits;Removal;Resort;Sbir;Sbirs (R43/44);Safety;Series;Sight;Silicones;Site;Small Business Innovation Research;Small Business Innovation Research Grant;Stress Tests;Structure;Structure Of Lens Capsule;Surgeon;Surgical;Surgical Instruments;Surgical Interventions;Surgical Procedure;Surgical Removal;Surgical Incisions;Technology;Temperature;Testing;Therapeutic;Therapeutic Intervention;Thick;Thickness;Time;Tissues;Vacuum;Validation;Vision;Visual;Visual Perception;Work;Adult Human (21+);Anterior Chamber;Artificial Lens;Base;Capsule (Pharmacologic);Cataract Surgery;Cataractogenesis;Cataractous Lenses;Children;Clinical Test;Corneal;Cost;Design;Designing;Device Artificial Lens;Disability;Disease /Disorder;Disease/Disorder;Elastomeric;Implantation;Improved;Incision;Instrument;Intervention Therapy;Interventional Strategy;Lens;Lens Capsule;Manufacturing Process;Meetings;Membrane Structure;Model;Nano Meter Scale;Nano Meter Sized;Nano Scale;Nano Scale Science;Nano Tech;Nano Technology;Nanometer Scale;Nanometer Sized;Nanoscale;Nanotech;Novel;Pediatric;Phase 1 Study;Prototype;Research Clinical Testing;Resection;Skills;Stress Tolerance;Success;Surgery;Youngster

We propose an innovative microtechnology-enhanced surgical device that solves a significant therapeutic bottleneck in the treatment of lens cataract in children. As the leading cause of childhood blindness, lens cataract interferes with the optical performance of the eye and if untreated, results in lifelong deficits in visual perception. The first step in pediatric cataract surgery is technically the most challenging and involves the creation of a hole in the thin and highly elastic lens capsule to provide access for the subsequent removal of the diseased lens and if needed, the implantation of an artificial lens. Due to the unique biomechanical properties of the immature lens capsule, adult procedures for creating the capsulotomy opening, if applied to infants and young children, only have a 20% chance of success. Capsule tears hinder lens removal and affect the mechanical stability and performance of artificial lens implants. Currently, pediatric cataract surgeons must make do using devices with tissue chopping functions originally designed for non- cataract surgical uses, resulting in suboptimal pediatric lens capsulotomies. In order to simplify and automate pediatric lens capsulotomies and thus enhance the delivery of vision care to young patients, we propose a disposable microtechnology-enhanced capsulotomy device to achieve consistent results across a range of surgical skills. The device is based on a proprietary method of tissue cutting in which a microfabricated cutting ring is housed within a collapsible elastomeric housing to produce precise capsulotomies on a sub-millisecond time scale. Our device is inserted through the standard 2.8 mm corneal incision and re-expands to produce a desired capsulotomy of 5 mm in diameter. In Phase I, we sucessfully demonstrated project feasibility by developing device protoypes that met specifications in terms of dimensions for intraocular use, compressibility, and capsule cutting. In the proposed Phase II studies, we will develop a commercial version of the capsulotomy device, conduct engineering bench testing, and undertake surgical validation in an accepted rabbit model, with the goal of achieving product design freeze. In parallel, as a second aim, we will also develop a compact table-top console to provide power, timing circuits, vacuum, diagnostics, and safety alerts for the casulotomy device. Results from this Phase II work will allow us to advance to device certification by good laboratory practice (GLP) accredited facilities as required for clinical trial initiation and ultimte FDA approval.

Public Health Relevance Statement:


Public Health Relevance:
This work seeks to develop a microtechnology-enhanced surgical instrument to aid in the treatment of childhood blindness due to lens cataract. Lens cataract is the leading cause of pediatric visual disability, and cataract removal restores sight and improves the quality of life for both patients and their families. The proposed device simplifies and automates a technically challenging surgical task in pediatric cataract surgery.

Project Terms:
Adult; Affect; Animal Testing; Animals; Anterior; base; Biomechanics; Blindness; Caliber; Calorimetry; capsule (pharmacologic); Caring; Cataract; Cataract Extraction; Cell Survival; Certification; Child; Childhood; Clinical Engineering; Clinical Trials; commercialization; Consult; Cornea; Corneal Endothelium; cost; Data; design; Development; Development Plans; device Artificial lens; Device Designs; Devices; Diagnostic; Dimensions; disability; Disease; Effectiveness; Elasticity; elastomeric; Endothelial Cells; Engineering; Equipment; Evaluation; Excision; Eye; eye chamber; Failure (biologic function); Family; foot; Freezing; Goals; good laboratory practice; Housing; Human; Implant; implantation; improved; In Vitro; Infant; innovation; Intraocular lens implant device; lens; lens capsule; Life; Manuals; Measurement; Measures; Mechanics; meetings; Membrane; Methods; Metric; millisecond; Modeling; novel; Only Child; Operative Surgical Procedures; Optics; Oryctolagus cuniculus; Patients; Performance; performance tests; Phase; phase 2 study; pre-clinical; Procedures; Production; Property; prototype; public health relevance; Quality of life; Resort; Safety; safety testing; Series; Side; Signal Transduction; Simulate; skills; Specimen; Staging; Stress Tests; success; Surgeon; Surgical incisions; Surgical Instruments; System; Technology; Temperature; Testing; Therapeutic; Therapeutic Intervention; Time; Tissues; usability; Vacuum; Vacuum Pumps; Validation; Vision; Visual; Visual Perception; voltage; Work