Automatic Contrast Injector

Medical Device Classification : Class C

Technology Readiness Level : TRL4

Intended end use : Automatic delivery of contrast agent for facilitating coronary angiography and angioplasty

Product description :

The device consists of a hand held power drive and a disposable manifold. The disposable manifold directs the contrast to the catheter during delivery and suck the contrast agent from the reservoir. A 10ml syringe is attached to the manifold and kept in the socket of the power drive. A trigger switch provided on the rear end is used for operating the device. The device is designed to have a sterile placement of the manifold and the syringe combination to be used in the clinical environment.

Novelty : Coronary angiography and angioplasty are the most common procedures in a catheterization lab. During this procedure, the performing physician aspirates angiographic contrast into a syringe and injects it through the catheter into the coronary artery and simultaneously do fluoroscopy and acquires the cine-run. Simultaneously he has to monitor the pressure at the tip of catheter also. A manifold system is used to facilitate this procedure. During a complex angioplasty, the operator may have to make more than 100 similar injections and on a busy day an operator will be doing many cases. A simple and cost effective automatic system can reduce the burden on the operator and his fatigue can be lessened. With such a system the clinician should be able to adjusts the force of injection, based on his tactile feel, pressure in the system, visibility with a small amount of contrast etc. The total procedural time also can be lessened, improving the efficiency of the system. No such simple system exists in India as of now.
The Chitra Automatic Contrast Agent Injector is a hand held device which can be used for injecting contrasting agent automatically during the procedure of coronary angiography/angioplasty. The device pushes the contrast injector through a manifold to the catheter when triggered by a press switch and automatically refills the contrast agent for the next shot. Thus the manual procedure can be automated reducing the physical burden, injuries and less exposure to the radiations. Key novelties are provided below
# The device is motorized so no need to manually push or pull the syringe piston
# Non return valves (NRV) is attached to the manifold so that there is no need to turn the valve knobs every time to refill and discharge the contrasting material
# Accurate and constant volume delivery can be performed


Current Development stage/ Evaluations done :The device prototypes are fully developed and is currently at TRL 4 with in-vitro tests performed in mock circulatory loop mimicking the human system. The device can push contrast agent at clinically required flow rate and refill for the next shot in an automatic way. The device is tested with mock circulatory loop with various pressure settings and flow settings. Use case scenario checked in Cath lab clinical setting with clinical team.

Industry responsibility :
# Preclinical evaluation
# Clinical evaluation
# Regulatory

Deliverables from Institute : Technology Transfer documents
Technical support for preclinical/clinical evaluations/regulatory