Laparoscopy surgery, or keyhole surgery, has been increasingly popular amongst surgeons. As minimally invasive surgery is commonly performed, finding a way to improve the technique is a challenge. This is just what the team at DOME Medical Technologies Inc. have achieved. However, DOME’s vision is laparoscopic surgery access, simplified. Recognized as Corporate Vision’s Most Influential Leader in Medical Device Operations 2020 – USA, we look at how this firm is changing the face of medicine the world over.
Laparoscopy is one of the more straight-forward operations that surgeons undertake, but like all procedures, it still holds the potential for serious complications. DOME Medical has committed itself to ensuring that every laparoscopic surgeon has the tools to make this minimally invasive operation even less dangerous. For them, access to the body can still be made safer, easier and more efficient.
The way that DOME Medical has done this is through the design and development of cutting-edge and next-generation surgery access devices. Taking it’s considerable portfolio of intellectual property, the team worked on the development of new medical devices that can be used to access the body for surgery and other medical procedures. The focus has recently been on LapDome, an innovation that could change the way that laparoscopies are performed.
LapDome has been designed specifically to provide a more sophisticated entry into the abdominal cavity for patients undergoing surgery in this region. It’s telling that the act of performing the surgical access has not really altered for roughly thirty years, with clamps manually lifting the abdominal wall and a Veress needle injected into the gap. This can cause complications, with injuries caused to major blood vessels, abdominal wall hematomas, bowel perforation and puncture of the aorta and a reported injury rate of 2.1%. These are acute or intra-operative complications. This does not include unreported access complications which present at a date following the surgery.
Through the use of a carefully designed molded polycarbonate dome, with a port that can be attached to a suction system and a port through which surgical equipment can be inserted like the Veress needle, when placed over the operating area, negative pressure suction from standard or suction systems raise the abdominal wall above the critical organs.
As the abdominal wall is raised above the vital organs, the Veress needle can be inserted into the newly created space with minimal risk of harming the vital organs that can be found in the abdominals. As inert gas is delivered to replace the negative pressure, the LapDome is removed and it is possible to begin the surgery. Everything is carried out without using manual clamps, which means the surgeon can perform the procedure without the aid of any assistants.
LapDome is an entirely proprietary creation, meeting the high industry standards of ISO 13485. Despite being a Class 1, non-intrusive device, it is designed for single use, with features built in to discourage re-sterilisation and reuse. This means that there is less chance of cross-contamination between operations, reducing the possibility of complications further down the line.
While laparoscopies are often held as one of the least intrusive and more minimally risky operations, this is a ground-breaking development that represents a new and significant advantage to surgeons. It not only reduces the time needed for insufflations, but it minimises the need for multiple access incisions and potentially reduces the risk of injury to underlying vessels. Current access modalities are not only labor intensive, but clearly contain inherent risks. Even the most routine and low-risk procedures can be improved, and it’s clear that this is the mindset with which the team at DOME Medical have approached the problem. It is a new way of tackling an old problem, addressing a clinical need that is not immediately obvious. Understandably, it has been well received throughout the medical community.
LapDome is a veritable boon to any surgeon, being the preferred option for anyone performing the operation. It means that there is a clear market wanting to use the product, namely laparoscopic surgeons, especially GYN surgeons, and the medical centers at which they practice. With over a hundred procedures successfully completed using LapDome as an intrinsic part of the process, every surgeon that has taken part has indicated that they would use the device when it was generally available, and more importantly, that they would recommend its use to junior surgeons.
In many ways, the success of LapDome, and the work of DOME Medical, is in finding new ways in which to innovate the medical industry. With its justifiably high level of regulation, there are major challenges for anyone wishing to work in this industry while also trying to find a commercial angle. It’s important to remember that these regulations are not arbitrary, and ensure that the medical community, and indeed the community at large, are served to the best of their ability. Devices that enter this sector are sure to be of the highest standard, both safe and effective in their function. The expertise of DOME Medical’s executive staff guarantees that the company is able to maintain these high standards, as well as it serves the medical community.
Looking forward, DOME Medical has been working on a series of exciting plans for the new year, starting with the team’s intention to launch LapDome on a limited basis across the US and Europe. This is naturally dependent on the attitude of the regulatory bodies in these two territories, specifically the US FDA and the notified bodies in Europe. This commercial launch would be preceded by DOME Medical conducting the Rapid and Positional Insulflation Device Registry. This is how the company intends to introduce the LapDome platform to the GYN surgery community, as well as measure the critical criteria such as safe use, ease of use, and other clinically significant points.
While LapDome has been the lynchpin of DOME Medical’s operations to this point, the culmination of the project will allow the company to explore new areas of commercial medical science. Having found a way to improve laparoscopies for the general population, the intention is to address more specialist needs in the future too. This means looking towards paediatrics, bariatric surgery, and other specialty patient applications.
To this end, the company intends to release a range of LapDome, each adapted to suit different needs and purposes. The LapDome™ Mini is the second version of the platform designed to fulfil the requirements of patients who are of a smaller body size than the original LapDome was designed for. The LapDome™ Pedi is similarly adapted, this time to suit the somewhat smaller and special clinical needs of pediatric patients. Laparoscopic surgery for this group is rising quickly, yet the specialized needs of these patients means that specialist tools are required to ensure a successful operation. LapDome 2.0 has design features which address the open access technique employed by General Surgery. Finally, the fourth iteration of the LapDome is the LapDome™ Plus, adapted to provide efficient access to the bariatric patient.
The best solutions are those which seem obvious once carried out, and this could be said of DOME Medical. Instead of pushing into uncharted territory, this firm has focused on perfecting what is already being done. Helping patients in the long run and providing a product that medical practitioners will be crying out for, the LapDome is set to take the market by storm.
Contact: Arthur Malvett