Medical innovations of the future, healing patients today.
SafeGuard Surgical provides needed products that will ensure safer surgery for superior patient outcomes while reducing costs, preventing additional surgical interventions and reducing patient length of stay, but most importantly preventing mortality and morbidity which is much too common risk from surgery.
Our mission is a scalable and sustainable innovative global outreach to improve surgical outcomes in advanced surgical procedures adapting US ideas in underdeveloped and advancing outcomes in contemporary nations.
Our focus is attention specific to emerging markets, underserved and developing nations to prevent common leaks that have alarming mortality rates in the international community.
The United States is the world's largest medical device market and it shows no signs of slowing. The US medical device industry was valued at $155 billion in 2017 and is projected to grow significantly through 2019, when it should increase to $173 billion. Overall healthcare spending is 17.1% of GDP.
We work with surgical oncologists, general surgeons, colon and rectal surgeons, and bariatric surgeons. Current products and services in development are
Despite advances in modern colorectal surgery, anastomotic leak continues to be a significant cause of morbidity and mortality.
Anastomotic leak is one of the most dreaded complications of operations of the large intestine. Breakdown of an anastomosis results in increased morbidity and mortality and adversely affects length of stay, cost, and cancer recurrence. Reported rates of anastomotic dehiscence vary between 1% and 30% with low colorectal and coloanal anastomoses posing the highest risk. Leaks also result in increase in hospital costs and increase length of stay. The best treatment force has the management of anastomotic leak has not yet been identified, especially in very low anastomoses.
Traditionally, the treatment of choice for a leaking colorectal or coloanal anastomosis had been resection of the anastomosis with exteriorization of the proximal limb as an end colostomy (Hartmann’s procedure). This removes the source of sepsis- albeit at increased cost and increased physical and psychological stress to the patient. Also, in the majority of cases, it leaves the patient with a permanent stoma, with less than 50% of patients ultimately undergoing reversal.
It stands to reason that any modality aimed at mitigating the sequelae of such a leak would bring a great deal of value to the field. In the current invention, we propose that placing a bio absorbable stent within he lumen of a newly created anastomosis would indeed lessen the chances of significant physiologic problems associated with a leak and perhaps avoid a subsequent operation with its incumbent costs, morbidity and mortality.
The LeakGuard prosthesis is a biodegradable intraluminal stent that when placed just after creation of an intestinal anastomosis- provides the opportunity to mitigate against A POST OPERATIVE leak. Furthermore, the biodegradable nature of this protection- is relatively short-lived and dissolves over 10-14 days.
In short, we think that the intraoperative placement intraluminal device holds clinical promise to reduce or prevent early leakage of colo-rectal anastomoses and concomitant sequelae.
The introduction of circular end-to-end stapling devices (CEEA OR EEA stapler) into colorectal and gastric bypass surgery have revolutionized anastomotic techniques. The EEA stapler is generally regarded as an instrument that is safe, reliable, and simple to operate.
In colorectal surgery, the end-to-end (EEA) stapler technique has allowed the creation of very low anastomoses (connections between the colon and anorectum) to be performed that were previously thought to be extremely difficult with suture. Suture of an anastomosis below 7 cm from the anus has been associated with a very high incidence of anastomotic leak. The stapler technique offers a clean, safe method for very low anastomoses of colon to rectum with a resultant anastomotic leak rate of less than 5-7% in experienced hands.
Despite it’s popularity, very little information is available regarding the technical difficulties encountered during surgery. The routine technique to perform an end-to-end circular colonic anastomosis is to introduce the instrument distally through the anus (transrectal/transanal approach) and attach it to the anvil which is often secured by a purse string suture at the distal end of the proximal bowel to be anastomosed.
The anvil essentially serves as the end-plate of the stapler to turn the two rows of staples inward (like with the stapler on any desk). There is a circular knife that cuts the excess tissue within the lumen…to create a circular connection and a resultant end-to-end anastomosis.
One of the problems that the surgeon faces is the fact that you really need to ensure that the staples actually land within and close upon “good tissue” in a circumferential manner. The surgeon thus inspects to ensure that the stapler has retained two complete "donuts" of tissue. If not, there are staples that did not form the connection properly and the result is a dreaded anastomotic leak.
To avoid incomplete stapling, one must have close approximation around the anvil- which is harder than the drawings make it look….. a purse string closure around the anvil is often not technically simple nor feasible especially with laparoscopic/robotic procedures, thus the concept of a folding anvil (like an umbrella) to minimize the opening of the bowel becomes a very desirable option.
We are proposing is an anvil that actually folds like an umbrella, and may be inserted into the bowel through a very tiny hole (rather than the big circular anvil that one must then either create a purse-string suture to approximate the tissue around it ( or insert it first, staple across the bowel and then poke it through the intestine afterward).
The anvil would then be opened fully within the bowel and the stapler would be deployed with greater ease of use and a much higher likelihood of obtaining two robust donuts.
SaferStapler was designed to prevent the occurrence of anastomotic leaks. Such leaks are extremely dangerous to the well-being of the patient and add enormous expense to the patient and the system as a whole. These leaks often result in re-operation and placement of a colostomy (a bag that drains the stool directly from the colon to the skin).
The SaferStapler prevents and preempts the need for a colostomy bag and subsequent operation to reverse it (if it is even feasible at that point).
Every surgeon would agree that any additional operation risks the patient’s safety and health outcome, furthermore it doubles and possibly triples the cost of healthcare.
SaferStapler’s accurate anvil is a cutting edge solution to prevent the morbidity and mortality of these complications and mitigate excessive healthcare costs, while simultaneously preventing multiple unnecessary operations.
Copyright © 2019 SafeGuard Surgical LLC