Significant development work is bringing minimally invasive surgery to a new level. Widely used trocar designs enable only one surgical device to go through at a time. This means that a patient may have up to eight trocars in place during a procedure. Recent developments are focused on allowing multiple instruments to be simultaneously inserted into a single trocar. The technology substantially reduces the number of incisions, thereby reducing scarring and potential for infection. It even allows surgery to take place through the navel.

Such advances, however, place an even stronger demand on the performance requirements of the seal designs and formulation of the material. Up to three instrument shafts could be in close proximity to each other, and the movements of one instrument affect the seals around the other instruments. Great care must be taken in creating seal designs that accommodate these demands.

Another very recent area of surgical development, natural orifice transluminal endoscopic surgery (NOTES), enables a surgeon to use natural orifices (like the mouth) for surgical entry. Although these are new procedures and product development is just beginning, such surgery is expected to significantly improve outcomes and recovery, as well as reduce some common surgical risks. It is also expected that seal requirements for NOTES product applications will be particularly demanding. Sealing devices will certainly be used in the orifice, but there may also be a need to have seals for incisions inside the body to gain access to specific areas.

Conclusion

Seals are one of the most important components of trocars, and really for most medical devices in general. Trocar seals have very specific material performance requirements that are not easily met. OEMs must understand these needs and require a scientific, data-based approach for seal development. Selecting the material, designing the part, testing, and validating the designs are all essential steps in a successful seal program. Such a program is likely best served by forming early partnerships with companies that have knowledge and experience in rubber materials and sealing applications.