Medical grafting methods & apparatus

#This invention relates to medical apparatus, and more particularly to apparatus for use in making anastomotic connections between tubular body fluid conduits in a patient.

#There are many medical procedures in which it is necessary to make an anastomotic connection between two tubular body fluid conduits in a patient. An anastomotic connection (or anastomosis) is a connection which allows body fluid flow between the lumen of the two conduits that are connected, preferably without allowing body fluid to leak out of the conduits at the location of the connection. As just one example of a procedure in which an anastomosis is needed, in order to bypass an obstruction in a patient's coronary artery, a tubular graft supplied with aortic blood may be connected via an anastomosis to the coronary artery downstream from the obstruction. The anastomosis may be between the end of the graft and an aperture in the side wall of the coronary artery (a so-called end-to-side anastomosis), or the anastomosis may be between an aperture in the side wall of the graft and an aperture in the side wall of the coronary artery (a so-called side-to-side anastomosis (e.g., as in published Patent Cooperation Treaty (“PCT”) patent application WO 98/16161, which is hereby incorporated by reference herein in its entirety)). The graft may be natural conduit, artificial conduit, or a combination of natural and artificial conduits. If natural conduit is used, it may be wholly or partly relocated from elsewhere in the patient (e.g., wholly relocated saphenous vein or partly relocated internal mammary artery). Alternatively, no relocation of the graft may be needed (e.g., as in above-mentioned application WO 98/16161 in which a length of vein on the heart becomes a “graft” around an obstruction in an immediately adjacent coronary artery). More than one anastomosis may be needed. For example, a second anastomosis may be needed between an upstream portion of the graft conduit and the aorta or the coronary artery upstream from the obstruction in that artery. Again, this second anastomosis may be either an end-to-side anastomosis or (as shown, for example, in above-mentioned application WO 98/16161) a side-to-side anastomosis. Alternatively, no second, upstream anastomosis may be required at all (e.g., if the graft is an only-partly-relocated internal mammary artery).

#The currently most common technique for making an anastomosis is to manually suture the two tubular body fluid conduits together around an opening between them. Manual suturing is difficult and time-consuming, and the quality of the anastomosis that results is highly dependent on the skill of the person doing the suturing. In the case of coronary artery bypass procedures, one source of difficulty for suturing of an anastomosis may be motion of the heart. There is also increasing interest in procedures which are less invasive or even minimally invasive. Such procedures have potentially important advantages for patients, but they may increase the difficulty of performing manual suturing of an anastomosis by reducing or limiting access to the site within the patient at which the anastomosis must be made. Various examples of such less invasive or minimally invasive procedures are shown in above-mentioned application WO 98/16161, Goldsteen et al. U.S. Pat. No. 5,976,178, Sullivan et al. U.S. Pat. No. 6,120,432, Sullivan et al. published PCT patent application WO 98/55027, and Berg et al. U.S. Pat. No. 6,475,222, all of which are hereby incorporated by reference herein in their entireties.

#FIG. 1 is a simplified sectional view of the apparatus and a first conduit in accordance with the invention.

#FIG. 2 is a planarized projection of a component apparatus of FIG. 1 in accordance with the invention.

#FIG. 3 is a perspective view of the component apparatus of FIG. 2 in accordance with the invention.

#Although the invention has other possible uses, the invention will be fully understood from the following explanation of its use in providing a bypass around an obstruction in a patient's vascular system.

#FIG. 1 illustrates the apparatus 100 in accordance with the invention, which is illustrated along with a connector structure 200, and a first conduit 10, which is typically a graft conduit and may be a natural conduit, such as a saphenous vein graft (SVG) or similar, or an artificial conduit. Apparatus l00 comprises a number of component elements for delivery and deploying the connector apparatus 200 and the first conduit 10 to the operative site to make an anastomotic connection between first conduit 10 and a second conduit, which is typically a patient's natural body conduit (see, e.g., FIG. 21). An apparatus for deploying the connector structure 200, such as balloon catheter 300, is useful for enlarging the connector structure 200 to join the two conduits. A nosecone apparatus 400 is useful to assist insertion of apparatus 100 into an aperture in the second conduit and to shield the connector structure 200 from damaging the second conduit during such insertion into the second conduit. A location ring 500 is positioned about an aperture 12 in the first conduit 10 and about the connector structure 200. The location ring 500 may be helpful to indicate the position of the first conduit 10 and the connector structure 200 during the anastomosis procedure.

#Apparatus 100 and connector structure 200 are particularly useful in making a side-to-side anastomosis between the first and second conduits. This procedure accommodates the connector structure 200 to different sizes of conduits, provides an anastomosis size approximately equivalent to the second conduit diameter, and provides an optimal takeoff angle for the first conduit to prevent kinking. Apparatus 100 and connector structure 200 are also useful in making an end-to-side anastomosis.