A system for sealing a percutaneous puncture communicating with a blood vessel in a living being and method of use thereof. The system, referred to in the present embodiment, as a balloon closure device, includes an inner member, referred to as an anchor catheter, slidable within an outer member, referred to as an occlusion catheter, and separate expandable members, referred to as balloons, coupled to the distal ends of both the anchor and occlusion catheters. Also, incorporated into the distal end of the anchor catheter are blood vessel locator holes for determining the position of the blood vessel via the percutaneous puncture. The vessel locator includes means for enabling blood from the vessel to flow therethrough so that the position of the vessel can be rapidly determined. Once the balloon closure device has been extended into the puncture and the vessel has been located, the ballon closure device may be deployed. The anchor catheter and its balloon are located within the blood vessel, while the occlusion catheter and its balloon are located within the puncture tract leading to the vessel. Once the balloon closure device is positioned, hemostasis occurs rapidly, and the necessary components are locked in place.
A proximal end of the occlusion catheter includes a port for delivering fluid into the balloon, and a cylindrical lumen that communicates with the port. A proximal end of the anchor catheter includes a port for delivering fluid into the balloon, and a cylindrical lumen that communicates with the port. The anchor catheter may also include a cylindrical lumen to accommodate a guidewire. The balloon closure device is introduced like a standard sheath exchange. First, the existing sheath is removed over a guidewire. Next, the occlusion catheter coupled with an inner distally tapered anchor catheter/introducer is passed over the guidewire through the puncture, disposing the anchor catheter/introducer with its collapsed balloon in the vessel lumen, while the occlusion catheter with its collapsed balloon is disposed in the puncture tract. Once vessel lumen location is confirmed, fluid is introduced into the anchor catheter port, inflating the anchor balloon. The anchor balloon is withdrawn to seal the puncture. The occlusion catheter is advanced to the distal end of the puncture tract just outside the vessel wall, and abutting the inflated anchor balloon. Fluid is introduced into the occlusion catheter port, inflating the occlusion balloon, to both occlude the puncture and secure the occlusion catheter in the puncture tract. The anchor balloon is then deflated, allowing the anchor catheter/introducer to be withdrawn into the puncture tract and removed. Once hemostasis is confirmed, the guidewire is removed. After an interval, the occlusion balloon may be deflated to check for hemostasis. Once hemostasis is confirmed, the remaining occlusion catheter may be removed, leaving nothing behind but the body's own hemostatic plug.