SMART MINIMALLY INVASIVE INSTRUMENTS
Electrical and optical systems at the tip of minimally invasive instruments add eyes and ears at the point where surgeons need them the most.
The enormous capabilities of the ECS industry in miniaturization, integration, embedded intelligence, communication and sensing will have an enormous impact on the next generations of smart minimally invasive devices.
While our phones, cars and houses are filled with low-cost, unobtrusive sensors able to provide a wealth of information, most minimally invasive devices today, aside from some smart catheters used in cardiac interventions, are inuntelligent instruments without sensor functionality at all.
Many interventions such as biopsies, ablations, intravenous infusions and epidural needle placements, lead extractions etc. are all still performed based on experience, or simply guided by ultrasound or fluoroscopy.
Highly miniaturized electrical and optical systems realized using advanced cost-effective platform technologies will bring extensive imaging and sensing capabilities to these devices, and enable the second minimally invasive surgery revolution.
Minimally invasive surgery is one of the most effective instruments to reduce the cost of healthcare. Compared to open surgery it has led to a drastic reduction in hospitalization, trauma to the patient and post-surgical complications. Not surprisingly, minimally invasive surgery is now being used in almost every branch of surgery, and as a result, the number of minimally invasive interventions has grown immensely over the past two decades.
An example in which minimally invasive procedures will have a tremendous impact is in the treatment of atrial fibrillation (AF). In the last 20 years AF, which is strongly related to age, has become one of the most important public health problems. It is estimated that the patient population with AF in Europe will have reached 14-17 million in 2030, with between 120 and 215 thousand new cases of AF each year. Until recently, the only therapies available have been either the prescription of drugs or – extremely impactful - open heart surgery. Today, a growing number of patients is treated using a minimally invasive procedure. Smart catheters will increasingly enable the surgeon to know where he has to treat, how to reach the position, and how deep the ablation is progressing. This will shorten procedures and improve procedure outcomes, enabling the cost effective treatment of a growing number of patients.
Relevance for the Electronic Components and Systems (ECS) industry
Today, the potential of highly miniaturized electrical and optical systems for smart minimally invasive instruments is largely untapped. Application of electronic sensing functionality remains primarily limited to coronary interventions, and even there the products in the market today use outdated analog technologies based on expensive point solutions.
The field is desperately waiting for universal open technology platforms that can be used to fold, wrap, and squeeze complex electronic sensing systems into the tip of these tiny instruments. Digitization at the tip will lead to serialization of data, which in turn will result in standardization of communication protocols. Seamless integration of these products in the cath lab infrastructures will further promote their proliferation.
With approximately 7-10% of the aging population expected to undergo at one moment in their life a cardiac intervention, this type of interventions alone, which are entirely based on disposable devices, will represent a significant business prospect for the ECS community.
Enabling technology platforms
To realize the next generation smart catheters, a broad spectrum of advanced ECS capabilities will need to be brought together, foremost in dedicated platforms for heterogeneous miniaturization and integrated photonics. These platforms are complemented with platforms for embedded ultrasound, low power edge computing and AI and digital health platform integration. Finally, it should be mentioned that the development of the next generation of smart minimally invasive instruments will go hand in hand with the development of new navigation techniques that do not rely on X-ray (see emerging domain “Towards radiation free interventions”).
H. Bezerra & G.S. Mintz, “Intravascular OCT and IVUS in PCI, an expert review,” American College of Cardiology, Jun. 13, 2016
P. Tonino et al. “Fractional Flow Reserve versus Angiography for Guiding Percutaneous Coronary Intervention,” Jan 15, 2009, N Engl J Med 2009; 360:213-224
A. Darge, “Advances in Atrial Fibrillation Ablation,” J Invasive Cardiol. 2009 May; 21(5): 247–254.