Surgical Access System for Frugal Bariatric Surgery

Bariatric/metabolic surgery has become popular for weight reduction. In 2011, 340,768 bariatric surgeries were performed worldwide; 101,645 of these operations were performed in the United States and Canada [1]. In addition, in emerging counties, overweight and obesity are rapidly increasing [2,3]. Bariatric surgical procedures are mainly performed by two modalities: open surgery or minimally invasive laparoscopic surgery with single and multiple points of entry. Both approaches generally require patients to be subjected to intubation and general anesthesia. Moreover, in the laparoscopic surgery, patients require carbon dioxide insufflation of the abdomen as well, and from one to multiple incisions for access points to deploy all endoscopic instrumentation. Therefore, conventional surgical procedures require the use of a general anesthesia equipment system, and an expensive laparoscopy platform. These systems cost hospitals millions of dollars. Besides, in terms of safety aspect, several problems are pointed out. Laparoscopic insufflation with CO2 has been demonstrated to give circulating CO2 levels with possible deleterious effects, as well as increasing resistance to lower extremity and pelvic venous return to the heart. Tracheal intubation is not benign and can result in postoperative discomfort, tracheitis hoarseness and ventilator associated pneumonia, and albeit rarely, vocal cord damage.The purpose and motivation of our research is to offer a solution to the above problems, and achieve “Safer” and “Cost-effective” bariatric surgery. So far, we have investigated performing bariatric and other surgery with a micro-orifice incision (75 mm) without the need for general surgery, laparoscopic insufflation, and tracheal intubation [4]. We have conducted particularly the bariatric procedures of gastric stimulating electrode placement and adjustable gastric banding, in the pig experimental laboratory under sedation/local anesthesia, using Propofol, and without general anesthesia, abdominal insufflation, and tracheal intubation. The animal studies were successful, allowing for the operations to be performed totally under Propofol sedation and local anesthesia without the animal experiencing any discomfort manifested by movement, agitation, or a change in the pulse, blood pressure, and respiratory parameters. This success has allowed us to initiate micro-orifice surgery, without general anesthesia, abdominal insufflation, and tracheal intubation.However, the negative aspect of our micro-orifice surgery approach is a lack of abdominal wall relaxation to provide safe organ visualization. Thereby, it is difficult to create a sufficient workspace within the abdomen, especially in case of a sleeve gastrectomy. In this paper, to offer a solution to this problem, we designed a medical device that would provide access to the abdominal cavity of a patient and make it easy to perform bariatric surgery with a micro-orifice incision under sedation/local anesthesia. It is clear that with obesity on the rise worldwide, the United States is not the only country that could benefit from a safer and more cost-effective solution, which is accessible to a wider range of hospitals and populations. Certainly, large populations in developing countries could benefit from a new low cost and safer system. Using this device, intubation, general anesthesia, insufflation, and laparoscopic platforms are not required; in other words, “Frugal Safer Surgery” can be achieved.A new surgical access system has been developed that can provide an optimal workspace within the abdominal cavity of the patient using a single small incision. The proposed device combines, three important aspects of the surgical setting: access, retraction and illumination. In addition, the device eliminates the need for carbon dioxide insufflation, minimizes post-surgical pain, and avoids large incisions or multiple small incisions to obtain surgical access. Surgery can be conducted under IV sedation/local anesthesia, without general anesthesia and intubation. It offers direct visualization, rather than the two-dimensional laparoscopic view, and allows for the use of standard, long, or laparoscopic instruments.Figure 1 shows the new access device (patent pending). When the device is inserted into the patient's abdomen and the cylinder A is being rotated, the blades slowly expand pushing back tissues and internal organs because of the screw and linkage mechanism. Therefore, this device can provide for an adequate workspace in the abdominal cavity. Since the device's tip is pointed, it is easy to insert the device into the abdominal wall.Figure 2 shows the cross section view of the device. The external diameter at the insertion point is small, 75 mm. This feature allows the surgery to be conducted under IV sedation/local anesthesia, without general anesthesia. Surgical instruments such as forceps can be inclined up to 60 degrees, and the surgeon can have wide-range viewing and accessibility in the abdominal cavity. Also, in the future prototypes, the blades will be inter-changeable, hence patient's skin thickness can be compensated for by having available blades of varying lengths.Several bright LEDs are built-in into the blades as shown in Figure 3, providing light to the workspace in the abdominal cavity. Thus, additional external light sources are not necessary.Figure 4 shows the holding device, which is another aspect of this invention. The access device can be inserted into the holding device. Because this holding device has a ball joint, the access device position can be inclined up to 60 degrees. Once the appropriate angle is determined, the position and angle are fixed using a lock mechanism. As shown in Figure 5, these devices can be inserted and held onto a patient via a Velcro tape connector to the surgical drapes.Following detailed design and analysis, several prototypes of the access system were developed. Figure 6 shows the latest access prototype. Engineering bench tests were conducted, and we confirmed that this device could create an adequate working space in the abdominal cavity, and have enough force transfer and rigidity to push away the tissues and internal organs. In addition, the high intensity LEDs adequately illuminated the abdominal cavity (see Fig. 6). In Vivo and cadaver testing is warranted and will be conducted in the future.We propose a surgical access system for frugal bariatric surgery. The developed device could create appropriate workspace in the abdominal cavity and illuminate the cavity. The surgeon can easily view and have access to the abdominal organs. This alternative surgical access system offers a new modality for surgeons whether or not it is used in conjunction with IV sedation/local anesthesia. The access system makes unnecessary the use of intubation, general anesthesia, endoscope and carbon dioxide insufflation and lavish laparoscopic systems. In addition, since field retraction is achieved by the device, the surgical assistant is free to support the surgeon as needed, possibly eliminating the need of an additional surgeon/nurse assistant as well. In summary, the system has the potential to reduce the time, overall cost and risks of pre-operative, intra-operative and post-operative care. The devices described and depicted in this work, are unique as compared to other devices found in the literature and patents' search [5–13].Although additional tests are required, we believe that this innovative system is a simpler, safer and more cost-effective surgical alternative. The system would be useful not only in developed countries but also in the developing world.

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