British boiler engineer Tal Golesworthy has created an implantable device to fix a pumping problem with his heart.
He was even able to convince doctors that the device could be effective at addressing connective tissue defects caused by Marfan syndrome, an inherited disease linked to cardiovascular problems.
Nine years ago, Golesworthy developed a device to treat the aortic complications stemming from the disease. He found inspiration in his back yard: He observed that a garden hose that had a bulging section or leak could be repaired using waterproof adhesive tape. "It's that crude and simple, and we have all done it in our gardens,” he told the BBC. Similar to a water hose with a bulging section, an enlarged aortic valve can also expand over time. The condition can cause mitral or aortic valve regurgitation and aortic aneurysm or other problems.
|Golesworthy's team used rapid prototyping to create a 3-D model of the aorta. They investigated a number of techniques before settling on selected laser sintering. They then made a textile implant to fit the model.|
Golesworthy set about developing a sleeve that fit around his enlarged aortic valve. Enlisting a cross-disciplinary team of engineers, CAD coders, and surgeons, they worked to develop a custom sleeve suited for the task.
Golesworthy is not the only nonmedical person to make it into the news recently for helping to design a medical device. There is the story of Argentine car mechanic Jorge Odón and how he was inspired by a method for extracting a cork from the bottom of a wine bottle using a plastic bag. The result was an invention for facilitating obstructed labor during childbirth.
In the case of Golesworthy's team, there were some challenges along the way related to the variety of disciplinary backgrounds represented.
For example, the team used horizontal MRI and CT images from Golesworthy's chest to create a CAD model. They developed an early model of the aorta, but then noticed it was a mirror image of the actual aorta.
As it turns out, CAD programmers are used to creating top-down models. In the medical realm, however, it is more common to look at plans from the other way around.
The team, though, overcame such communications challenges and gradually refined the CAD models. They used 3-D printing techniques to create tangible versions of them. Using the models, the team was able to create an aortic sleeve that would fit outside of the aorta. Made of polyethylene terephthalate, the sleeve weighed under 5 g.
Following four years of development and research, the device was ready for implantation in a first-in-man trial. The candidate would be Golesworthy himself.
The device proved as effective at treating the bulging valve as the garden hoses Golesworthy had repaired in the past. Now, more than 40 other patients have received the personalized versions of the device.
Since Golesworthy received the device, he has had minimal complications and has not needed to take blood-thinners, which can cause a variety of unpleasant side effects and a severe risk of bleeding.
Before setting out to develop the device, Golesworthy observed that there was no safe or effective treatment for his condition. At that time, which was in the early 2000s, this condition was often treated by replacing part of the aortic vessel with an artificially-designed graft. In some cases, surgeons also implant metal heart valves to replace excised ones. Patients with metal heart implants often required long-term use of blood-thinners to avoid clotting.
Golesworthy has gone on to set up a company known as Exstent to commercialize the technology.
- Changing a Colorant in an Approved Medical Device, What Should I Know? - Webcast
- Reduce Risk! Control Costs! Get to Market Faster! The Customer Solution Centre is Your Pathway to Successful Device Development. - Webcast
- Innovating within Cost Constraints to Get More Bang for Your Buck - Webcast
- Conformal Coatings for Tomorrow’s Medical Technologies - Webcast
- ISO80369 Standards Bring Changes to Medical Device Companies - Webcast
- Automation in Machining - Webcast