Cardiac introducer to access coronary sinus

This technology is a device configured to access the coronary sinus (CS) in the heart to deliver therapeutics, provide access for medical devices, and diagnose disease.

Unmet Need: Safe lead insertion for cardiac resynchronization therapy

In cases of congestive heart failure, cardiac resynchronization therapy (CRT) reduces morbidity and mortality and can improve cardiac function and cardiac output. To perform CRT, it is necessary to access the CS, yet many challenges exist for accessing this part of the heart including insertion, locating the CS, lead delivery and stability, vein selection, and avoidance of diaphragmatic pacing. Despite their wide usage and benefits, CRT fails in approximately 8-13% of attempts to access the CS. Faster and more reliable CS access is needed and could lead to important diagnostic and therapeutic advances.

The Technology: A small, flexible introducer for inserting a pacemaker lead to the coronary sinus

This technology is a device configured to facilitate the access to the coronary sinus (CS) from an incision close to the right atrium. The device includes a tubular part with a curvature corresponding to the curve of the left ventricle portion of the CS and a second curve corresponding to a curve of a branch vein of the CS. Different angles can be employed for the curvature of the tubes allowing for the device to be personalized to each patient. In addition, the introducer’s fit can be tested in silico based on 3D images of the patient’s heart, enhancing the likelihood of a successful intervention. A prototype cannula has been tested in postmortem human specimen.

Applications:

• Introducer for cardiac resynchronization therapy, ventricular assist devices, or valve prostheses
• Minimally invasive bypasses
• Cardiac delivery of therapeutics
• Intracardiac imaging

Advantages:

• Can be customized based on 3D images of the patient’s heart
• Improves safety and accuracy of lead insertion
• Reduces the length of the insertion procedure
• Covers approximately 90-95% of all variations in a patient population
• Physical proximity to the CS
• More flexibility in approach angles, leverage, and imaging
• Less size limitation vs. endocardial—allows echocardiography probes and multichannel prototypes
• Applicability to all CS interventions, including stents, mechanical circulatory assistance, and CS occlusion
• Adaptability for percutaneous intervention

Lead Inventor:

Henry M. Spotnitz, M.D.

Patent Information:

Patent Status

Tech Ventures Reference:

• IR CU14198, CU15272, 2680

• Licensing Contact: Sara Gusik