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LOUISVILLE, KY, United States

An apparatus includes a tubular member defining a lumen and a channel, and a support member. The tubular member has a connection portion configured to be coupled to an organ wall. An outer edge of the connection portion is configured to contact a first portion of an inner surface of the wall when the connection portion is in an expanded configuration such that an interior volume of the organ is in fluid communication with the lumen. The support member is movably disposed within the channel and is configured to minimize movement of the wall relative to the tubular member. An end portion of the support member is disposed within the channel when the support member is in a first configuration. The end portion of the support member configured to contact a second portion of the inner surface of the wall when the support member is in a second configuration.

A system for ablating internal heart tissue in an ablation pattern on a surface of the tissue within the heart. The system includes an ablation catheter with a distal end having an ablating tip portion operative to allow selective ablation of tissue. A guiding device is engageable with the ablation catheter and includes a tissue anchoring portion operable to engage with tissue proximate to the tissue to be ablated so as to temporarily anchor the guiding device relative to the tissue. Engagement of the guiding device with the ablation catheter operates to assist with guiding the ablating tip portion in moving along the pattern. Various devices and methods of use are further disclosed.

Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 1.58M | Year: 2009

DESCRIPTION (provided by applicant): SCR, Inc. (Louisville, KY) is developing a chronic implantable CPD system to treat HF patients who may be responsive to long-term counterpulsation support. The CPD has been developed for superficial implantation via a pacemaker incision without the need to enter the chest and enables complete patient mobility. The CPD is a 32-ml stroke volume polyurethane-lined blood chamber designed to fit comfortably in a subcutaneous pocket on the right anterior chest contralateral to an implantable cardioverter defibrillator (ICD) or biventricular pacer device implantation site. The pumping chamber is connected to the systemic circulation by a short ePTFE graft anastomosed to the axillary artery. The CPD is controlled by a small, wearable pneumatic driver, connected by a percutaneous air line, and triggered by the patient's ECG. The CPD fills during native heart systole lowering ventricular workload, and ejects during diastole augmenting myocardial and end-organ perfusion. In the phase I study, the hemodynamic efficacy of the 32-ml CPD driver was equivalent to a standard commercially-available 40-ml IABP in a large animal model (n=12) over a range of physiologic conditions (hypotension, hypertenstion, and heart failure) demonstrating feasibility. In this phase II study, the development and testing of the CPD driver will be completed to support a future FDA submission. This objective will be accomplished by (1) completing engineering development, (2) demonstrating reliability and ergonomics, and (3) demonstrating long-term safety of the CPD driver. Results of a pivotal Good Laboratory Practices (GLP) study will be completed with a summary report prepared for submission to the Food and Drug Administration (FDA) to request approval for clinical trials. The program detailed here leverages the development work of SCR and the engineering and development teams at Abiomed (Danvers, MA). This partnership will be assisted and guided by an innovative group of physicians at Jewish Hospital (Louisville, KY) and a world class research team in the Cardiovascular Innovation Institute (CII) at the University of Louisville (UofL). Our long-term objective is to successfully introduce the CPD system into the clinic as a long-term counterpulsation therapy to treat late NYHA class III and early NYHA class IV HF patients and help restore their quality of life. PUBLIC HEALTH RELEVANCE: SCR, Inc. (Louisville, KY) is developing a long-term counterpulsation device (CPD) to treat early stage heart failure patients. The CPD has been developed for superficial implantation without the need to enter the chest and a portable pneumatic driver that the patient can carry restores mobility.

Embodiments of the present disclosure relate to constructing an Object Analytic Record (OAR) that may be used to store data from one or more sequential chains. Analytics may be performed on data in the OAR to generate ratings for one or more components of a supply chain or the supply chain itself. Analytics may also be performed on the OAR to provide a certification for a supply chain or for a supply chain components and products.

Scr, Inc. | Date: 2011-08-25

Systems and methods are disclosed for tracking information related to events. Event information may be stored in a digital sequential chain. The sequential chain stores information related to the event as it occurs over a period of time. The sequential chain allows for the relation of multiple events resulting in an event chain. The information in the event chain may be related using a unique identifier.

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