Manometrically-Monitored Introducer Needle and Method of Use

Congestive Heart Failure (CHF) affects over 5,000,000 people in the U.S. alone and its incidence is growing. As the number of CHF cases grows, so will the rate of Ventricular Tachycardia (VT). Implantable Cardioverter Defibrillators (ICDs) can prevent sudden death from VT and drug therapies are often combined with ICDs for long-term patient management. However, the currently available VT drugs may have limiting side effects for such patients.

Another approach to treating VT is the endocardial ablation of faulty tissue. Endocardial ablation as a treatment for VT is only 30-50% successful in the long-run. One reason for this is that only 15-50% of VT is endocardial. Recently epicardial ablation from a subxiphoid approach has been performed at a few specialty centers, most notably at the INCOR hospital in Sao Paulo. One significant limitation to the widespread adoption of epicardial ablation procedures is that there is no tool specifically designed and optimized to access the pericardial space. Currently an ablationist must use a short needle designed for lumbar punctures.

Dr. Srijoy Mahapatra, M.D., an electrical engineer, practicing clinician, and an expert in epicardial ablation in the Division of Cardiology and Dr. George Gillies, Research Professor of Mechanical and Biomedical Engineering at the University of Virginia, have combined their talents to develop a series of tools that can be used for epicardial ablation procedures. In the present invention, Dr. Mahapatra and Dr. Gillies have created a needle specifically designed for pericardial access in patients without an effusion. It has four advantages:

• It is longer and can be used in obese patients
• It has a small, retractable, sharp tip for crossing the diaphragm and pericardial sack. When retracted the needle is soft and minimizes damage to the stomach and heart
• It measures pressure manometrically. A major advantage of this approach is the measured pressure is an accurate indicator of the position of the needle’s tip and can provide the clinician an easy-to-use tool to help guide the needle’s movement towards the epicardial surface.

This method has been tested clinically in a preliminary trial involving three human patients. The ability to measure pressures point-to-point within the chest significantly assisted the clinician in targeting the needle and obtaining epicardial placement of the ablation catheter. In addition, this needle offers the following additional advantages:

• Limit safety risks from hemodynamic collapse
• Retractable sharp edge for ability to cut tissue as needed
• Ability to delivery therapies only into the pericardial space

This needle invention completes a package of exciting medical devices developed by the Mahapatra/Gillies team that are specifically optimized for epicardial ablation procedures.

Inventor(s): Mahapatra, Gillies

Type of Offer: Licensing



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