Turning Passion into a Product The Development of Canon Medical Systems' Dynamic Device Stabilizer

Ischemic heart disease accounts for approximately 20% of deaths worldwide. The main medical intervention is endovascular treatment, through which, narrowed heart vessels are opened from within. Endovascular treatments place less burden on the patient, but require a high level of skill to perform. Devices must be placed at the treatment site - a beating heart - with absolute accuracy.

With DDS, X-ray images of the area subject to treatment are acquired continuously. Devices that also move with the heart, are detected in each image. Motion correction is applied, so that the devices appear in the same position in each image. Enlarged and enhanced dynamic images are immediately displayed. In other words, devices that would normally keep moving along with the heart appear stationary in the real-time fluoroscopy image viewed by the physician. This improves the visibility of devices and is expected to improve placement accuracy.

Mr. Takemoto has worked alongside Dr. Sakaguchi since 2008. They collect clinical data from the sites visited and bring it back to the office to process, improving the technology and brushing up their ideas.

“Mr. Takemoto comes up with ideas that I would never think of,” remarked Dr. Sakaguchi. “I don't think that this patent would have been completed if it were just me working on it.”

“I often come up with ideas when I am actually observing clinical practice. I try to pay close attention to situations in which the physician is having difficulty or where the physician and technician aren't communicating well and the procedure is not going smoothly. These are the moments in which I think that there might be something we can do to make treatment easier,” said Mr. Takemoto. “It is difficult to really grasp what physicians are facing by just listening to explanations or looking at information that we receive from somebody. Even if you listen to the words of a physician describing their needs or concerns, it is difficult to understand the real intentions of those words.”

“By actually wearing a surgical gown, washing your hands, and entering the cath lab to stand next to the physician, you can finally understand their point of view,” added Dr. Sakaguchi. “Once the procedure begins, you will witness bleeding and falling heart rates. By watching how staff react to these events, you can think about how our systems should operate to be the most useful.”

Mr. Takemoto thinks that a lot can be learned about clinical practice from academic conferences streamed online, but emphasized that onsite visits are fundamental.

“With video, you can see the physician's hands, or you can view fluoroscopic images with added audio, but there's a lot more going on at actual clinical sites,” he said. “I think there is a big difference in the amount of information that can be obtained onsite versus online. With video, you can't feel the tension in the room, or see the movement or signs of distress of staff who aren't visible on the screen.”

Once the development team assimilated their ideas, the next step was to apply for a patent. Patents create the shape of the future. To ensure they are successful, demand, passion, and quantity, are all essential.

“There are two things that I think are necessary for invention,” said Mr. Takemoto. “The first is that there is a real clinical need for the idea, physicians and technicians must really want it. The second is that you, as an engineer, have the passion to turn that idea into a product. Even if a patent is not immediately of practical use, it may become useful in the future.”

“I always say that quantity is much more important than quality regarding patents. If you don't produce quantity, the quality won't improve. So, for the first 10 years, I think that producing quantity is more important,” remarked Dr. Sakaguchi. “As Mr. Takemoto says, patents don't apply to the present, but rather, they apply to 10 years in the future. Even if a great engineer comes up with 100 patents, it is still difficult to know if the inventions will be successful or not in the future. Only after 10 years have passed and times have changed will we start to understand.”

“Of course, it's important for young engineers to be able to work quickly and efficiently, but on the other hand, new things are happening daily at sites and clinicians are facing new challenges. I want young engineers to not only be satisfied with completing the tasks at hand but to go further and look closely at what is happening in clinical practice so that they can figure out what to tackle next,” he added.

“When I first saw the DDS technology, I thought that it was a good to have but a difficult technology to implement,” said Mr. Shiraishi. “I was amazed by how well the algorithms and processing methods were devised. I felt we should do our best to bring it to market as soon as possible.”

“I thought that the concept idea itself was very interesting. I first saw an image of a moving heart during a live demonstration at an academic conference that I attended,” said Mr. Watanabe. “Dr. Sakaguchi was watching the live demonstration with me, and I remember him commenting: "It's hard to see moving images, I think it would be easier for the physician to see if we could stabilizethe image." I remember being surprised because stabilizing the image was such a unique solution to the problem.”

“The concept itself is very simple, it just involves finding something specific in an image. However, since there are many structures in the body that appear similar to the markers, it is really difficult to identify the two correct markers in a noisy image,” added Mr. Yamaguchi.

The DDS development team met a few hurdles in bringing DDS to market, which they overcame.

“Marker visibility depends on various factors such as the way X-ray is applied, the C-arm angle, and reflections of bones,” explained Mr. Watanabe. “The difficult thing about DDS is that it has to accurately detect markers in realtime in a variety of conditions.”

“To be usable in clinical practice as a real-time display, the time from image generation to marker detection must be a matter of milliseconds, but that is not possible at the basic research stage. At the commercialization stage, we must get to the several-millisecond range but also must balance the tradeoff between performance and speed,” he added.

“With the heart, you don't always find what you're looking for in the middle of the monitor,” said Mr. Shiraishi. “What you need is for the physician to realign it on-site, but they often don't have time for that.”

“When it comes to commercialization, another difficult thing is that even if the technology is amazing, if it is difficult to use, or if the processing is too slow to keep up with medical procedures, the product will fail,” said Mr. Yamaguchi.

“If you have experienced the tension of an operating room, you will know that you can't ask a physician to ‘just click here once’,” explained Ms. Takaya. “If you create a product without this knowledge, it likely won't be accepted by physicians.”

Ms. Takaya explained some of the feedback.
“Because stents are difficult to see in normal fluoroscopic images or digital acquisition images, users want to use this software to confirm stent position,” she said. “I have received many comments such as "I want to use this software because of those times that I can't see the stent properly."”

“The way that angiography systems are used differs depending on the facility and the physician, even if the procedure is the same. Similarly, DDS is used in variousways, with some physicians only using it during digital acquisition, and others also using it during fluoroscopy,” she said.