Apparatuses and methods for use in surgical vascular anastomotic procedures

Inventors

Orion, Eyal • Harari, Boaz

Assignees

Vascular Graft Solutions Ltd

Abstract

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).

Core Innovation

The invention relates to an apparatus for use in surgical vascular anastomotic procedures that performs clampless end-to-side vascular anastomosis, including coronary artery bypass grafting. A blood vessel inner wall sealing and hole forming device is configured to atraumatically establish and maintain, inside a blood vessel lumen along a blood vessel inner wall segment, a peripheral seal around a needle sized hole in the blood vessel inner wall segment, absent of blood flow, and to form an anastomotic hole through the peripherally sealed blood vessel inner wall segment.

A hole sealing device includes a hole sealing assembly with a reversibly expandable non-activated, collapsed configuration and a reversibly collapsible activated, self-expanded configuration. A sheath externally fully covers and closely fits over the hole sealing assembly in the collapsed configuration, and is configured to entirely enter into the blood vessel lumen by passing through the needle sized hole and along the blood vessel inner wall segment. Manual hole sealing controller assembly is operably connected to the sheath for manual control, and a flexible control wire and flexible tube guide motion and reversible activation of the hole sealing assembly.

An anastomotic hole generating device and a hole forming actuator are configured for reversible connection and operation of the inner wall sealing and hole forming device. In one implementation, coaxially arranged tubular outer and tubular inner assemblies are linearly translatable and slidably movable forward and backward along a concentric longitudinal axis, with a tubular anastomotic hole generating member that passes through the needle sized hole distally and generates and exits the anastomotic hole proximally. In another implementation, the hole forming actuator includes nested tubular assemblies that use a circular groove, manually controllable guiding members, and manually controllable connector members to facilitate reversible connection to the sealing and hole forming device.

Claims Coverage

The partial content includes four independent claims, each centered on atraumatic peripheral sealing around a needle sized hole in the absence of blood flow, followed by generating an anastomotic hole through the peripherally sealed blood vessel inner wall segment, with reversible actuation and specific mechanical structures for control and hole generation. Across the independent claims, the inventive features concentrate on a hole sealing assembly with manual sheath/wire control, a coaxial tubular anastomotic hole generating device, a circular groove-based actuator connection, and operation while maintaining the peripheral seal before, during, and after generating the anastomotic hole.

Across the independent claims in the partial content, the core claim coverage centers on an apparatus and method for blood-flow-absent atraumatic peripheral sealing around a needle sized hole, followed by generating an anastomotic hole through the peripherally sealed inner wall. The mechanical inventive focus is on a reversibly activated hole sealing assembly held by a sheath with manual control via flexible wire and tube, and on a reversibly connectable hole forming actuator that uses nested coaxial tubular motion to pass through the needle sized hole and generate and exit the anastomotic hole.

Stated Advantages

Documented Applications