Aging and certain other diseases can cause weakening of the aorta (the main artery from the heart to the lower body) and other arteries, such as the femoral and iliac arteries. The localised dilation of a vessel is called an aneurysm. Over time, the aneurysm can grow weak enough that it can rupture. The incidence and prevalence of AAA (Abdominal Aortic Aneurysm) and other arterial diseases increase with age. In adults 65 to 80 years, the prevalence is 4% to 7%. AAAs and other aneurysms can be treated with conventional (open) surgery, endo vascular repair (EVAR) or laparoscopic surgery.
Until ten years ago, essentially all vascular anastomosis were performed by open surgery using conventional hand suturing. Suturing the anastomosis is a time-consuming and difficult task, requiring much skill and practice on the part of the surgeon. It is important that each anastomosis provides a smooth, open flow path for the blood and that the attachment be completely free of leaks. Substantial morbidity accompanies the open procedure, resulting in a protracted recovery period. Further, the procedure entails a substantial risk of mortality. While surgical intervention may be indicated and the surgery carries attendant risk, certain patients may not be able to tolerate the stress of intra-abdominal surgery. It is, therefore, desirable to reduce the mortality and morbidity associated with intra-abdominal surgical intervention. Hypothermia, blood loss, and recovery time are major concerns. The procedure requires an average hospital stay of 9.9 days in uncomplicated cases and recovery time is about 6-8 weeks.
An Israeli SME has developed an innovative vascular device, delivery instruments (for insertion and fixation) and a suture-free open and laparoscopic surgical procedure, which significantly enhances the existing treatment of aortic and peripheral aneurysms, arterial occlusions and blood vessel traumas, avoiding the perioperative and late complications involved with other methods.
The device is used to connect any standard vascular graft to the blood vessel of a patient. The device can be used for both elective and emergency treatments for blood vessels with a diameter larger than 5mm. It can also be used in cases of large vessel trauma and is suitable for complex anatomy cases in which endograft can not be used. The first selected application, for which all types of trials were performed, is the abdominal aortic aneurysm. Currently, the minimal neck of the aneurysm should be longer than 1.5 cm.
The complete product for open application has five components: an elastic tube (the graft), terminal docking heads, an inversion device, a diameter probe and a graft holder (forceps). In laparoscopic procedures, the docking head implanted is identical to the open operation but the procedure and the surgical equipment used is different. The kit for the laparoscopic procedure includes measuring tools, diameter probe, delivery and insertion devices.
The device offers the following competitive advantages that are expected to lead to reduced mortality rate, shorter hospitaliation and ICU time and a reduction in the procedure cost:
- Reliable vessel connection that provides unrestricted, smooth blood flow.
- Leak-proof, migration-free, permanent anastomosis.
- Reduced blood loss.
- Simplified graft implantation procedure and easy handling.
- Blood flow interruption for only 2-5 min.
- Compatible with any standard vascular graft.
The same quality of anastomosis can be also achieved for a minimally invasive laparoscopic procedure using the device. Additional benefits for this type of surgery include:
• The technology is an enabling technology for the laparoscopic procedure and makes AAA and Aorto-iliac repair possible without unreasonably lengthy and technically difficult surgeries.
• A laparoscopic procedure is much more flexible when dealing with anomalies than endoscopic procedures.
• Laparoscopic aneurysm repair is expected to compare very favourably with the cost, frequent complications and technical difficulties involved in endovascular repair, thus it has the potential to replace a very large number of endovascular procedures.