Extremity vascular injury results in bleeding and lack of blood flow beyond the site of vessel disruption (ischemia). Priorities when this occurs include hemorrhage control, management of life-threatening injuries, and restoration of flow to the extremity. While definitive vessel repair is optimal, life-threatening injuries often prohibit this option. Alternatively, a temporary vascular shunt (a small-caliber hollow plastic tube) may be placed in the uninjured segments of vessel above and below the disruption to restore blood flow until conditions improve, and the shunt can be removed and repair performed.
Current shunts were designed by vascular and neurosurgeons for use in age-related vascular disease — not for injury. Shunts have found increased use in the treatment of traumatic vascular injuries and the like, particularly those suffered on the battlefield. In such circumstances, shunts are used to treat combat-related vascular injuries. Shunts in the arterial position allow for perfusion of the extremity during transport or fixation of associated orthopedic injuries. For injury patterns involving an artery and vein, shunts placed in the venous position provide drainage and decrease venous hypertension that can compound tissue ischemia and bleeding.
The temporary shunts currently employed provide some advantages but suffer from several deficiencies. Available shunts are of suboptimal size, length, and diameter. Moreover, they have no capability for injection into the injured vessel and have no name recognition among trauma surgeons. Many of these technologies were designed and approved for use in carotid surgery for perfusion of the brain for a short period of time, rather than for temporary use in complex trauma-related vascular injury. As a result, the shunts currently used to treat traumatic vascular injuries are difficult to use and insert into damaged blood vessels.
A trauma-specific vascular injury shunt (TS-VIS) represents a breakthrough in the management of extremity vascular injury. The device has been designed by combat surgeons and military researchers to allow this capability to be applied in different operational environments including civilian and wartime. Its features also minimize the risk of complications, ensure its adaptability to the unique needs of patients, and allow infusion of therapeutic (therapeutic reperfusion) or contrast agents (angiography) into the injured limb.
The TS-VIS provides a short-term (<24 hours) implantable device that can be used by qualified medical personnel to temporarily restore blood flow to a person's injured extremity following a complex trauma-related vascular injury. The TS-VIS can remain in place for several hours or longer to restore perfusion in the affected body area until the patient can be transported to a tertiary care or similar medical treatment facility where a permanent vascular repair can be accomplished, at which time the TS-VIS is removed. The TS-VIS significantly improves the salvage of damaged limbs by restoring and maintaining the flow of blood and fluid to those limbs until the vascular injuries can be permanently repaired.
The TS-VIS works by inserting the ends of the shunt into the respective portions of a damaged vessel. The ends of the shunt are secured in the vessel and the flow of blood is monitored through the shunt. Blood, medicine, contrast media, and/or other fluid can be provided to the traumatic vascular injury via the shunt. The patient is transported to a medical treatment facility, where the injury is permanently treated and the shunt is removed.