Apparatuses and Methods for Use in Surgical Vascular Anastomotic Procedures
Apparatuses and methods for use in surgical vascular anastomotic procedures. Apparatus includes a blood vessel inner wall (BVIW) sealing and hole forming device, and a hole forming actuator. BVIW sealing and hole forming device includes a hole sealing device, and an anastomotic hole generating device. Hole sealing device includes a sheath that fully encloses and holds a self-expanding hole sealing assembly, a manual hole sealing controller assembly, and a flexible control wire enclosed within a flexible tube. Anastomotic hole generating device includes outer and inner assemblies, with a conically shaped anastomotic hole generating member. Hole forming actuator includes outer and inner assemblies. Also disclosed are procedures for performing surgical vascular anastomosis using the disclosed apparatuses and methods. Particularly applicable for use in clampless types of (end-to-side) surgical vascular anastomotic procedures, for performing coronary artery bypass grafting (CABG).
1 . An anastomotic hole generating device for generating an anastomotic hole in a blood vessel inner wall segment, the device comprising:
a tubular outer assembly, having an outer assembly central tubular cavity extending along entire longitudinal length of said outer assembly; and
a tubular inner assembly, having an inner assembly central tubular cavity extending along entire longitudinal length of said inner assembly;
said inner assembly is longer than said outer assembly, and has a portion thereof concentrically surrounded by and closely fitting within and along said outer assembly, such that said outer and inner assemblies are linearly translatable, and slidably movable forward and backward in distal and proximal directions, relative to each other, along a concentric longitudinal axis thereof;
said outer assembly and inner assembly central tubular cavities are configured to facilitate reversible passage therethrough of a flexible tube or wire; and
said inner assembly has a distal end portion configured with a tubular anastomotic hole generating member that is configured to atraumatically pass through, via distally directed motion, a needle sized hole in the blood vessel inner wall segment, and to generate, via proximally directed motion, an anastomotic hole through the blood vessel inner wall segment, and to exit, via further proximally directed motion, said anastomotic hole generated through the blood vessel inner wall segment.
2 . The apparatus of claim 1 , wherein said inner assembly includes a spring, configured to control and limit said linearly translatable and slidable relative motion of said outer and inner assemblies.
3 . The apparatus of claim 2 , wherein said inner assembly includes a central tubular cavity inside of which is coaxially configured a longitudinal slot that houses said spring.
4 . The apparatus of claim 3 , wherein said inner assembly includes a pin that holds the proximal end of said spring in place inside said longitudinal slot.
5 . The apparatus of claim 4 , wherein said pin is housed in, and orthogonally extends across and through, the central tubular cavity of said outer assembly in the proximal end portion of said outer assembly.
6 . The apparatus of claim 4 , wherein said pin is held in place via a pair of two oppositely positioned holes located in the proximal end portion of said outer assembly.
7 . The apparatus of claim 3 , wherein the distal end of said spring is held in place inside said longitudinal slot via the distal end of said inner assembly central tubular cavity.
8 . The apparatus of claim 2 , wherein the proximal end portion of said inner assembly includes an inner protruding rim and an outer protruding rim, said inner protruding rim, along with said spring, is configured to limit said linearly translatable and slidable relative motion of said outer and inner assemblies, and said outer protruding rim is configured to facilitate reversible connection of the anastomotic device with another device.
9 . The apparatus of claim 1 , wherein the proximal portion of said outer assembly includes a protruding rim configured to facilitate reversible connection thereof with another device.
10 . The apparatus of claim 1 , wherein the distal portion of said anastomotic hole generating member is configured as a tubular cone having a circular base and a tapered point or apex.
11 . The apparatus of claim 10 , wherein the proximal end portion of said hole generating member tubular cone includes a non-beveled or non-tapered tubular segment that is continuous with, and proximally extending from, said hole generating member tubular cone circular base.
12 . The apparatus of claim 11 , wherein said tubular segment has a form of a ring, whose outer diameter is equal to the diameter of said tubular cone circular base, and whose longitudinal, proximal to distal, length is less than the proximal to distal height of said tubular cone.
13 . The apparatus of claim 11 , wherein the proximal end of said tubular segment has a sharp edge configured to cut through a blood vessel wall, from within said blood vessel inner wall segment, to outside said blood vessel inner wall segment, so as to generate said anastomotic hole through said blood vessel inner wall segment.
14 . The apparatus of claim 11 , wherein remaining proximally extending portion of said anastomotic hole generating member that proximally extends from said tubular segment is tubular shaped, with diameter being less than the diameter of said tubular cone circular base, and is configured as a tubular tail proximally extending from proximal end of said tubular segment to middle portion of said inner assembly.