Transatrial Catheter Access for Pericardial Space (BIDMC 191)

Category:    Medical Devices

KeyWords:  Surgery;  

BIDMC ID:    191

Abstract:

Background: Cardiovascular disease remains the leading cause of death in developed countries. In 2003 the combined worldwide market for cardiac markers, drugeluting stents, portable automated external defibrillators, and cardiac resyncronization therapy was estimated at $4.46 billion. An important problem in cardiology is the provision of a safe method and kit for diagnosing and treating the heart selectively and without thoractomy (open heart surgery). Currently, the only approved nonsurgical means for entering the pericardial space are the sub-xiphoid and the ultrasound-guided apical and parasternal needle catheter techniques. These methods carry significant risk of cardiac puncture and coronary laceration, and necessitate relatively advanced progression of disease with significant accumulation of fluid. A nonsurgical, percutaneous approach that could permit rapid, safe access to the normal pericardial space has the potential for considerable diagnostic and therapeutic utility. Invention: This new method and kit for accessing the pericardial space takes advantage of the fact that the right auricle is a thin walled, low-pressure structure, which can be readily penetrated without damaging the pericardium or the epicardium. The method includes the step of passing a guide catheter through a selected peripheral vein to establish a transvenous route to the right auricle of the heart. This new approach uses a catheter system for percutanous access into the undisturbed pericardial space through the right arterial appendage. The percutaneous approach via the right arterial appendage provides a rapid, safe route to access the normal pericardial space.

Inventor:   Richard L. Verrier Sergio Waxman

Commercial Opportunity:

The access route is potentially useful for selective examination and administration of therapeutic agents, growth factors, gene vectors, and cardioactive or vasoactive agents to the heart, and for placing defibrillation/cardioversion electrodes in contact with the heart without the need for a thoractomy.

Competitive Advantages:

Currently access to the heart is usually performed trough the sub-xiphoid route. Accessing the heart via the sub-xiphoid route entails a high risk of infection and can result puncturing, thereby, causing damage to the heart. Additionally, in order to deliver electrical stimuli directly to the heart, patients often undergo a thoractomy under general anesthesia. The invention presented here provides easy and safe access to the heart, minimizing tissue damage and infection, and providing access to the heart for delivering electrical stimuli, avoiding the need for thoractomy.

Related Publications:

·      Preclinical safety testing of percutanous transatrial access to the normal pericardial space for local cardiac drug delivery and diagnostic sampling. Sergio Waxman. Catheterization and cardiovascular interventions 49:472-477 (2000).
·      Subxyphoid Access of the Normal Pericardium: Anovel Drug Delivery Technique. Roger J. Laham. Catheterization and cardiovascular interventions 47:109-111. 1999

State of Development:

The new catheter system was tested in large animals. At the end of each of the 17 acute experiments, direct inspection after thoracotomy revealed no hemopericardium, laceration, or bleeding on catheter withdrawal

Related Technology URL:

http://research.bidmc.harvard.edu/research/ResearchPIInfo.ASP?Submit=Display&PersonID=718

Patent Status:

US patent No5,968,010 and 6,200,303 and counterpart foreign application have benn granted or are pending

TVO Contact Info:
     Catherine M Lenich
     Senior Associate TVO
     clenich@bidmc.harvard.edu
     Phone: 617-667-0568   Fax: 617-667-0646

     Beth Israel Deaconess Medical Center
     Technology Ventures Office  Room: BR-0200
     330 Brookline Avenue
     Boston, MA 02215