Luis Tissone | Director of Life Sciences | Trelleborg Sealing Solutions
Today’s surgical procedures are rapidly evolving within a highly technical healthcare environment. In the case of powered surgical instruments, the market is witnessing transformative and innovative advances, especially for neurological, ophthalmic, orthopedic, oral and cardiac surgical procedures. Constant advances have surgeons looking for higher-quality instruments that let them perform diverse surgical interventions rapidly and efficiently, without sacrificing patient safety. New and improved designs for powered surgical drills and screwdrivers are launched every year, providing a level of control, accuracy and performance never before achieved in the operating room.
The market landscape
According to Markets and Markets’ Powered Surgical Instruments Global Forecasts to 2019, the aging population, the exponentially growing number of global surgical procedures, and the increasing demand for minimally invasive surgeries, is fueling market growth of powered surgical instruments. The report anticipates a rise in the moderate compound annual growth rate through 2019 reaching $2.1 billion.
Incorporating the best components and technology in surgical drills and screwdrivers is providing positive results in surgeries, including reduced damage, heat, and trauma to the tissues as well as faster operations overall, and improvements in post-surgical healing.
An example of an innovative trend in surgical instruments is a new, cutting-edge powered screwdriver designed specifically for use in highly sensitive surgical procedures, which features sensors integrated with software to provide intelligence to the user.
In the most sensitive of procedures
Rigorous conditions for powered surgical instruments require flexible construction with a high-grade seal integral to the construction.
Since surgical drills and screwdrivers will be used in the operating room, a sterile and demanding environment, it is important that these surgical tools have a high level of reliability. This often comes with ISO certifications and FDA compliance.
Precision is critical because these screwdrivers are used for delicate procedures, such as neurosurgery to treat brain tumors or brain trauma caused by accidents. In these operations, a piece of the skull, either small or large and often of an irregular shape, is usually removed. After performing the surgery, the skull piece is reattached using a metal plate, sometimes held by 15 or more screws.
Rigorous development process
To design, develop and manufacture surgical devices, engineering teams of equipment manufacturers must work closely with the company’s material and component suppliers. They must also work internally with groups dedicated to ensuring product requirements are met by its suppliers, including reliability engineering, inspection services and quality control. Performance requirements are considered throughout the prototyping, design verification and validation processes, and the supplier is presented with any challenges they need to overcome.
Equipment manufacturers conduct many evaluations to find a good and proven supplier of components, such as seals, so they meet quality and longevity requirements.
Custom-designed solution
Suppliers to the life sciences industry must have strong knowledge and R&D experts on hand to assist in determining the best design to be integrated into equipment. One Trelleborg example is in the design of seals for a powered screwdriver, in which the seals needed to have a metal body to press into a bore without any retention or features to hold it in place.
It was a challenge to develop a press-fit seal designed to lock into the outside diameter to maintain a static seal. The seal was made of a high-grade composite of polytetrafluoroethylene-based resin with anti-wear additives, crimped inside a metal body that is press-fitted into the bore, creating a static seal and establishing a lip that will run on the shaft itself. As the shaft rotates, this lip sits and rides on top of it, delivering a low coefficient of friction.
A slant coil spring within the seal has an energizing property, maintaining a relatively constant load as it is deflected. As the seal wears or changes dimensions due to thermal variations, the force generated by the spring is constant. The force also helps ensure that the product has a long life and consistent heat generation.
The high quality needed for the important work of powered surgical drills and screwdrivers means the highest care must be put into the design process to produce precision instruments.
Meeting specific seal requirements
Powered screwdrivers and drills are currently being designed to minimize the amount of time it takes for surgeons to perform procedures, such as feeding screws into plates attached to skulls. Thanks to recent advances, 15 or even 20 screws are put into the plate in a matter of minutes.
The time saved, of course, depends on the type of surgery and how many plates and screws are involved. And the advances can potentially reduce operating room time and patient exposure to anesthesia, while also reducing stress on a surgeon’s hand. At the same time, surgical instrument manufacturers are attempting to extend the hours of operation and life of their instrument and need a seal that will perform over a long equipment life.
Withstanding cleaning regimes
Surgical screwdriver or drill applications require not only small but robust sealing solutions that can withstand sterilization in an autoclave or specialized washer. These processes subject the surgical device to high-pressure saturated steam at 121°C (250°F) for around 15 to 20 minutes, depending on the size of the load and the contents. As seals can deteriorate in these processes, it is vital that the right materials are specified to prevent seal damage. Compatibility of seal materials is a key element.
Emerging markets
The powered surgical instruments segment is large and growing, with new developments and technology constantly being introduced. The transition from traditional surgeries to minimally invasive procedures has helped fuel the growth of this market segment.
According to Markets and Markets, North America is expected to contribute the largest share to the global powered surgical instruments market in 2019. Europe will have the second-largest, with Asia-Pacific close behind. In the coming years, Asia-Pacific will yield the highest growth opportunities, as it begins to tap its market for surgical devices. From a sealing solutions supplier’s standpoint, there will be substantial opportunities to show leadership and support manufacturers in developing innovative equipment.
