Graft core for seal and suture anastomoses with devices and methods for percutaneous intraluminal excisional surgery (PIES)

摘要

Devices and methods are described for emplacing bypass grafts in any tubular tract in a mammalian body by natural or percutaneous entry and suturing intraluminally. A coronary bypass is used as the preferred embodiment. Prior art devices and methods for accomplishing this object are disclosed in patents but are not in use today. The prior art in use requires opening the chest so the surgeon can get his hands or tools in to manually tie ten or more sutures on each end of each bypass, each requiring a minute to tie. This produces extensive collateral damage to the chest, dangerously long heart stoppage, intensive care, excruciating pain and months of recovery. The devices of the present disclosure cause the patient no collateral damage, little discomfort, probably no more than overnight in hospital, and complete recovery within days. The devices are introduced percutaneously and advanced intraluminally by catheters with fluoroscopic, radiographic and other electromagnetic means of tracking through the body. A cutting device produces an opening in the aorta which is immediately clamped by a clamping catheter that inflates annular balloons on either side of the aorta wall around the opening. An explorer guidewire is advanced, with the aid of various tracking devices, through the opening and curved around the heart to the predetermined site of anastomosis on the coronary artery where the guide wire tip is emplaced. A delivery tube device, containing a natural or artificial bypass graft with graft core devices pre-operatively sutured to each end by hollow sutures, is advanced over the explorer guide wire. Template devices shape the ends of the bypass graft to optimally expose intimal layers for alignment those of the artery and aorta to improve the probability of rapid, healthy growth. The delivery tube device enters an opening as it is cut in the coronary artery by a cutting device mounted on its distal end. This briefly blocks the escape of blood while a push-rod device pushes the graft core out of the delivery tube. A brim section of the graft core, being released from its compressed state inside the delivery tube expands like a flange inside the coronary artery. This provides a leak-resistant seal between bypass graft and coronary artery while the push-rod device is fully inflated to align its rods with the stiff sutures inside the hollow sutures and pushes them through the edge of the tissue around the opening and into the brim section of the graft core flared inside the body tube. Barbs hold the stiff sutures in place. This suturing of bypass graft to aorta is accomplished with similar devices. A dozen sutures are emplaced simultaneously in less time than it takes to emplace one suture manually, thus reducing or eliminating use of a mechanical heart machine. This combination seal and suture anastomosis is logically more fluid-tight than one produced by manual suturing alone or seal alone. Eliminating collateral damage allows the known advantages of bypass grafts over stents to be realized in practice.