A Novel Catheter for Thrombolytic Drug Infusion Therapy to treat Pulmonary Embolism
一种新型溶栓药物输注治疗肺栓塞导管
基本信息
- 批准号:10547235
- 负责人:
- 金额:$ 25.88万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2022
- 资助国家:美国
- 起止时间:2022-09-10 至 2023-08-31
- 项目状态:已结题
- 来源:
- 关键词:3-DimensionalAccountingAddressAlteplaseAnatomic ModelsAnatomyAngiographyAnimal TestingAreaAutopsyBloodBlood VesselsBlood coagulationCaliberCardiogenic ShockCardiovascular systemCathetersCessation of lifeCharacteristicsCoagulation ProcessCustomCytolysisDataDecision MakingDetectionDevelopmentDevicesDiagnosticDistalDoseEffectivenessEnsureEnvironmentEvaluationEventFailureFibrinolytic AgentsHealth Care CostsHemorrhageHospital CostsHourIndividualInfusion proceduresInjectionsIntra-abdominalIntravenous BolusLasersLengthLifeLiquid substanceLocationLungLyticMeasurementMeasuresMedicalModelingMonitorMorbidity - disease rateObstructionPatientsPenetrationPeripheralPharmaceutical PreparationsPhaseProceduresProviderPulmonary EmbolismRadialRecipeRight Ventricular DysfunctionRiskSafetyShapesSmall Business Innovation Research GrantSystemTestingTherapeuticThrombusTimeTitrationsTorqueTranslatingTraumaTubeUnited StatesVenous Pressure levelWhole BloodWithdrawalbasedesigneffective therapyfluid flowheart damagehemodynamicshigh riskimprovedin vivomechanical deviceminimally invasivemortalitynitinolnovelparticlepersonalized medicinepressureprototypereal time monitoringrisk minimizationrisk of major adverse eventsthrombolysis
项目摘要
PROJECT SUMMARY
This SBIR Phase I project will focus on the development of a catheter specifically designed to reduce
bleeding complications from catheter-directed thrombolysis (CDT) treatment of pulmonary embolism (PE). PE
represents a leading cause of morbidity in the United States, with as many as 900,000 cases per year in the
United States alone. One in four patients with PE will die suddenly without warning, and PE is the third most
common cause of cardiovascular death. In addition, blood clots represent a significant burden on the economy,
with healthcare costs accounting for up to $10 billion dollars annually.
CDT involves placing one or more small catheters directly within the blood clot(s) in the lung(s) and
infusing a thrombolytic medication (e.g. tissue plasminogen activator) to dissolve the clots over a 2-24 hour
time period. It is preferred over a peripheral intravenous bolus administration of tPA in all but the highest risk
patients, as a slower, more controlled infusion correlates with lower rates of life-threatening bleeding.
While CDT-based thrombolytic infusions can be immensely effective, this therapy carries the risk of
major adverse events including catastrophic intracranial, vascular, or intra-abdominal bleeding, and the risk of
bleeding complications is proportional to the dose and duration of thrombolytic infusion. To minimize
this risk, the lowest possible dose of thrombolytic should be infused over the shortest duration. This ideal
endpoint would be the point when complete lysis occurs and any added thrombolytic only increases risk
without any therapeutic benefit. To date, no existing CDT device allows for personalized treatment and
real time monitoring of lytic effectiveness to allow for judicious titration of thrombolytic administration.
Customer discovery revealed that providers desire pressure data to inform treatment decision-making.
The proposed device is a CDT catheter which minimizes the dose of thrombolytic delivered. It does this
by enabling hemodynamic monitoring across a thrombus for real-time detection of thrombus disruption,
AND by deploying expanding nitinol lytic “baskets” for maximized thrombolytic contact area with thrombi. Its
all-in-one design makes the procedure easier, safer, and less costly for the hospital.
This catheter comprises two telescoping catheters wherein the outer catheter can be translated to
selectively expose preformed nitinol tubing baskets for adjustable-length three-dimensional lytic infusion.
The combined catheter system has four ports, each designed to address CDT milestones. The device will
allow the user to (1) precisely steer the catheter and sub-select a target branch, (2) perform high pressure
contrast injections to obtain diagnostic-quality angiograms, (3) infuse lytic in the full three-dimensional space of
the vessel to precisely fit and fully saturate the thrombus, and (4) measure real-time, continuous, simultaneous,
fluid-filled pressure proximal and distal to a thrombus to determining an appropriate therapy endpoint.
项目总结
项目成果
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