Eye Openers on Surgical Handheld Devices
How Fluoroelastomer Solutions Help Build Care Between Surgeon & Patient
By Brendan Owens (April 2021)
Technological advances made in surgical handheld devices in the form of design and fluidics have provided better control and safety for surgeons, ultimately establishing confidence between doctor and patient in critical surgeries. Among this segment of medical devices, ultrasound eye surgery remains one procedure that has benefited from these advancements, namely phacoemulsification cataract eye surgery or phaco for short.
Were you aware that phaco is about 50 years old? Over these five decades, the safety of phaco devices has significantly improved due to hundreds of incremental upgrades. As highly advanced pieces of medical equipment, the devices now offer advanced fluidics, IOP control, and anterior chamber stability. Within the handpiece itself are critical parts that make it even more stable such as fluoroelastomer seals, which protect the handpiece electronics and withstand autoclave / sterilization cycles up to 1,000 cycles.
The Rise of Cataract Eye Surgery
According to the Centre for Disease Control and Prevention, in 2015, around 20.5 million people in the U.S. (mainly those aged 40 years and older) suffered from cataracts, resulting in an increasing demand for cataract eye surgery and driving growth of the market during the forecast period.
About 50 years ago, the first phacoemulsification cataract surgery was performed by Charles Kelman, MD, (known as the “father of phaco”) in New York, in a four-hour procedure. Now, the phaco procedure can be completed in a matter of seconds due to a number of refinements in ultrasound systems, microsurgical incisions, and new hardware/software, which give surgeons a variety of power options, better control of fluidics, and improved chamber stability.
Phacoemulsification has become the primary method of cataract removal, resulting in a 98% success rate on all cataract surgery operations. It is a modern cataract surgery method in which the eye's internal lens is emulsified with an ultrasonic handpiece and aspirated from the eye. Aspirated fluids are replaced with irrigation of balanced salt solution to maintain the anterior eye chamber. The lens is replaced with an artificial intraocular lens (IOL).
The Rise of Fluoroelastomer Seals in Surgical Handpieces: Delivering Extended Performance
Why are fluoroelastomer seals successful in life science cataract eye surgery applications? The seal material has valuable properties in not only life science but also industrial, semiconductor, and pharmaceutical applications:
Excellent chemical resistance that potentially reduces inventory stock (cleaning solutions, etc.)
Superior compression set (as low as 11%) compared to conventional fluoroelastomer (FKM) and perfluoroelastomer (FFKM – 15%)
Excellent low temperature performance of -70°F (-57°C) with a maximum temperature of 427°F (219°C)
Withstands repeated exposure to autoclave / sterilization cycles
Softer durometers than perfluoroelastomers are available (<50 Shore A)
Unlimited shelf life, preventing discarding unused seals due to age
Custom shapes and sizes can be manufactured to typical dimensional tolerances (as small as 1/8” OD)
Excellent solution in systems with exposure to multiple oils, fuels & solvents
This sealing solution is used successfully by a global leader in eye care and one of the largest eye care device companies in the world who was developing a new surgical handpiece but experienced reliability issues using a standard silicon o-ring (FKM). Several handpieces experienced leakage, failing testing, while others did not. After detailed discussions, Omniseal Solutions™ offered a high tolerance, low compression set, custom-fit solution with USP Class VI compliance viability that could tolerate multiple autoclaving and sterilizations. The seals seemed to be the precise fit!
Omniseal Solutions™ expedited test samples that performed successfully. The customer verified the seals in-house to ensure USP Class VI compliance for the material. To date, there are two to three seals installed in each handpiece, providing these valuable benefits:
Protecting electronics during autoclaving and sterilization purposes: - 270°F (132°C) at 1 to 2 bars
Providing stability and control for a heavy-duty tool that is also considered disposable after 1,000 uses (a busy surgeon might perform 50 surgeries per day)
Tolerating the high speed piezoelectric vibration and micro-shuttling motion at the tip of the handpiece that is used to cut-up cataract tissue and suction
The Rise of Surgical Instrumentation Market
Fluoroelastomer solutions will continue to prove valuable with the rise of surgical instrumentation in the future due to increases in lifestyle diseases, healthcare spending, medical tourism and adoption of minimally invasive surgeries - all expected to further propel this market. Surgeons and medical staff do have the option of selecting and using precise equipment such as microsurgical tools or robotics as a result of advanced design and techniques; however, they need to find ways to reduce costs, improve sterilization processes, and enable quality assurance.
Omniseal Solutions™ is prepared for these challenges and ready to support life science customers with not only fluoroelastomer seals but other sealing solutions. Omniseal® spring-energized seals are also an excellent sealing solution for surgical handpieces, providing long life and sterilization cycles. The spring-energized seals are used in multiple medical applications such as HPLC/UHPLC and in vitro diagnostics.
Unsure what life science sealing or material solution will work for you? Contact the team of life science experts today to find out how to best support your needs and the medical communities who are protecting our health every day.