FOCUSSTART, LLC — Department of Health and Human Services SBIR Phase I: 100

Description

Abstract Patientsandaposneed for orthopeadic joint surgeriessuch a total knee replacement surgeryTKAandgtyearis growing at rates andgtper yearFailure to balance soft tissues such as ligamentsthat normally stabilize the body jointscan cause the surgical joint repair to fail prematurelye galmostof revision knee surgeries were linked to instabilityThereforebalanced soft tissue is considered critical for post operative successIn TKA surgeriesa difference between loads on opposing sides of a kneefemoral tibial inter compartmental load differencesandgtpounds was associated with worse postoperative functionGustke et alsuch as limited range of motionpainor implant looseningExperienced TKA surgeons have been unable to detect significant inter compartmental load differences as large astolbswhich suggests a demand for a quantitative tool to detect such load differencesElmallahIt is anticipated that a much greater number of less specialized surgeons will be performing joint surgeries by the yearbecause the supply of orthopaedic surgeons will likely not meet demand due to growth of the aging patient populationThereforethe demand for tools that assist orthopaedic surgeons of all experience levels may potentially improve prosthesis lifetime and enable greater standardization of routine proceduresCurrent commercial products are limited to the kneeexpensivenot adaptable to multiple ligament sizes with varying levels of accessibilitytraumatic to the target tissuesor they report overall loads but not tension of individual tissuesFocusStart has fabricated a simplenon destructiveinexpensive handheld device to reliably and accurately quantify soft tissue tension during orthopedic surgeriesOur previous work has established accuracy of our sensor for individual ligamentsthe next step in commercialization is to associate sensor output with resulting mechanical alignmentThis Fast Track proposal outlines the development of a modularstandalone handheld soft tissue tension sensorPhase I of the proposal will correlate ligament tension values to applied loads that experimentally induce varus and valgus knee imbalances in human cadaver kneesPhase II Aimwill develop a library of clinically relevant ligament tension values from normal and abnormal knees under varying amounts of experimentally induced knee imbalancePhase II Aimof this proposal will package the sensor system into a single physical deviceand qualify it for human useThe business plan is to develop and commercialize a tissue tension sensor initially for license to orthopaedic manufacturers for TKA surgeries Narrative Lack of balance among the soft tissues that normally stabilize body joints can cause surgical replacement of these joints to fail prematurelye galmostof revision knee surgeries were linked to soft tissue imbalanceCurrent commercial products are not commonly used because they are specific to a particular jointare expensivedifficult and time consuming to useand surgeons typically rely on their subjectivefeelof the joint to adjust tissue tensionsTo help surgeons improve joint balance in their exponentially increasing patient populationFocusStart has developed a simpleinexpensive handheld device to quantify soft tissue tension during orthopedic surgerieswhich will be further developed and tested in this proposal!