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Science Group Proves Feasibility for Catheter Concept

Most design firms offer basic services. We can handle even the most complex projects.

 

Engineering and designing these high-tech instruments can be especially involved when the client is not sure if their proprietary core technology will be feasible in practice. In the last few years, the challenge of transforming an intellectual property (IP) into a marketable device has emerged a prominent hurdle for prospective clients. They used to declare, "Here is, build it for us." Now clients are asking, "We have an idea. Do you think you can make it into a viable product?" 

 

Those seeking product development assistance need to recognize that most design and engineering firms offer only basic services. Their primary activity is to generate mainstream products. That’s what they do, and if the firm has been in business for some time, they are probably good at it.  

 

On the other end of the spectrum, there are firms that specialize in developing high-tech concepts into entirely original products. Ramping to this level requires a commitment beyond the usual collection of staff and equipment. The new medical device paradigm is one of the reasons we originally assembled, and continue to cultivate an Advanced Technical Services (ATS) group.                                     

             

 

Our six-person team is comprised of senior level employees and others with advanced degrees who specialize in the science-based analysis and practice of research and development. All of the members have the experience and expertise to address issues few product development firms are equipped to engage. They make key contributions on projects based on core technologies or IP that clients have hired us to incorporate into new or existing systems.

 

When Volcano Therapeutics came to Omnica, they presented the concept of a proprietary thermal basket catheter equipped with heat-sensing thermistors. Our assignment was to design a specialized cardio-diagnostic instrument with video monitoring capabilities that would incorporate the innovative catheter. But before we started work on what would be a considerable development effort, we had to answer a pivotal question. Would the catheter work as intended? 

 

Arterial "hot spots" are future locations of vulnerable plaque.

 

In a hospital setting a vascular surgeon would insert the catheter, a thin flexible tube terminated with six to ten temperature-sensitive sensors, into the patient's femoral artery and maneuver it through the body to a coronary artery. As the device is threaded through the heart's arteries, it should sense minute temperature changes in some locations. These spots are considered loci where arterial plaque may form. For our client's purposes, if the catheter tip could not measure clinically significant temperature changes, there was no reason to continue developing the project. Our challenge was to create a model that could simulate conditions the catheter would encounter in the human body, but in a controlled manner so we could determine its sensitivity.

 

The ATS group devised and assembled the testing model. They described protocol for the experiment and developed the operating platform and data collection software required to monitor the system. The goal as stated was to measure and record "hot spots" in coronary artery walls. If the catheter was accurate enough to consistently register a 0.05 degree Celsius temperature change during the artery model testing cycle, we would have proof of concept.

 

The system consists of a fluid pump and flow meter that circulates a saline solution (the same pH as blood) through a "coronary artery" made of specially molded silicone tubing. The base of the device contains an integrated heater that maintains a system temperature of 37 degrees Celsius (98.6 degrees F). For testing purposes, the catheter is inserted into the closed system through a hemostasis valve where it can be manually fed through the silicone "artery". Miniature heater modules mounted at certain points along the path are used to simulate the arterial "hot spots" the catheter had been designed to identify.

 

The testing concept worked as planned, and the client’s basket catheter concept was successful. We proved it could sense the arterial locations where intravascular vulnerable arterial plaque lesions were likely to form. After this feasibility phase we were hired to develop an entire system incorporating the new technology.

 

The result of the program was Volcano Therapeutics' intravascular thermography device. 

 

We designed a custom keyboard, the PC cart housing, a handheld control, and the video-based graphical user interface (GUI) for the operating software. Based on the successful completion of this project the company successfully raised millions of dollars for developing new technologies to aid in the diagnosis and treatment of heart disease.