Novel pericardial access device: design features and in vitro evaluation.

Area of Science:

• Medical Devices
• Surgical Innovation
• Cardiology

Background:

• Percutaneous access to the pericardial space is challenging due to the close proximity of the pericardium to the heart.
• Existing methods carry a risk of ventricular perforation.

Purpose of the Study:

• To design, build, and test a novel needle for safer percutaneous pericardial access.
• To minimize the risk of cardiac injury during pericardial interventions.

Main Methods:

• A 10-gauge needle with a unique single spiral tine at the distal tip was engineered.
• The device was tested using linear low-density polyethylene film as a pericardial surrogate.
• Engagement rates and required torques were measured at various approach angles.

Main Results:

• The novel needle demonstrated reliable pericardial engagement.
• Successful first-time engagement rates reached up to 72% (n=25 attempts).
• Engagement was effective at approach angles from 0° to 30° with low torque (~1 N mm).

Conclusions:

• The spiral-tined needle shows promise for safe and effective pericardial access.
• This device may reduce the risk of ventricular perforation compared to traditional methods.
• Further evaluation is warranted for clinical application in pericardial procedures.