Apparatuses and methods for use in surgical vascular anastomotic procedures
Inventors
Assignees
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Publication Number
US-11350937-B2
Publication Date
2022-06-07
Expiration Date
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 a hole sealing device configured to peripherally seal, inside a blood vessel lumen, a blood vessel inner wall segment from blood flow by atraumatically establishing a peripheral seal around a needle sized hole. The device forms a peripherally sealed blood vessel inner wall segment that is absent of blood flow. The hole sealing assembly includes a reversibly expandable non-activated, collapsed configuration and a reversibly collapsible activated, self-expanded configuration.
A sheath externally covers, closely fits over, and holds the hole sealing assembly in the non activated, collapsed configuration. The sheath is configured to atraumatically entirely enter into the blood vessel lumen by passing through the needle sized hole and along the blood vessel inner wall segment. A manual hole sealing controller assembly is operably connected to the sheath and is configured to facilitate manual control of the hole sealing assembly and the sheath.
A flexible control wire is fixedly connected to the inside distal end of the sheath and has a proximal portion fixedly connected to the inside distal portion of the manual hole sealing controller assembly. The flexible control wire controls motion and positioning of the sheath and reversible activation of the hole sealing assembly, while a flexible tube encloses, holds, and guides motion of the flexible control wire.
The described arrangement enables clampless end-to-side vascular anastomosis procedures, including coronary artery bypass grafting (CABG), by generating a peripheral blood-flow-free seal at a needle-sized puncture in the blood vessel inner wall segment. In this context, an anastomotic hole generating device passes through the sealed puncture and generates an anastomotic hole, using coaxially arranged outer and inner assemblies and a conically shaped hole-generating member with a hole forming actuator.
Claims Coverage
Independent claim clm-00001 covers a hole sealing device for peripherally sealing a needle sized hole inside a blood vessel lumen using a sheath-held, reversibly expandable atraumatic hole sealing assembly with manual control via a flexible control wire and flexible tube. The provided excerpt includes only this one independent claim; other independent claims are not explicitly included in the partial content.
Atraumatic peripheral hole sealing assembly with reversibly expandable configurations
a hole sealing assembly, configured to atraumatically establish, along the blood vessel inner wall segment, a peripheral seal around a needle sized hole in the blood vessel inner wall segment, so as to form a peripherally sealed blood vessel inner wall segment, absent of blood flow, said hole sealing assembly has a reversibly expandable non-activated, collapsed configuration and a reversibly collapsible activated, self-expanded configuration
Sheath that holds collapsed assembly and atraumatically enters through the needle sized hole
a sheath that externally covers, closely fits over, and holds said hole sealing assembly in said non activated, collapsed configuration, and configured to atraumatically entirely, with said collapsed hole sealing assembly, enter into the blood vessel lumen, by passing through said needle sized hole and along the blood vessel inner wall segment
Manual hole sealing controller assembly for manual control of sheath and activation
a manual hole sealing controller assembly, operably connected to said sheath, and configured to facilitate manual control of said hole sealing assembly and said sheath
Flexible control wire and flexible tube for motion/positioning and reversible activation
a flexible control wire, having a distal end fixedly connected to the inside distal end of said sheath, and having a proximal portion fixedly connected to the inside distal portion of said manual hole sealing controller assembly, and configured to control motion and positioning of said sheath and reversible activation of said hole sealing assembly; and a flexible tube, that encloses, holds, and guides motion of said flexible control wire
On the provided excerpt, claim coverage centers on a hole sealing device architecture that uses an atraumatic, needle-sized-hole peripheral seal with a reversible collapsed/non-activated and self-expanded/activated configuration, employs a sheath to hold and atraumatically introduce the collapsed seal, and enables manual control and reversible activation through a flexible control wire guided by a flexible tube.
Stated Advantages
A peripherally sealed blood vessel inner wall segment that is absent of blood flow.
Documented Applications
Clampless end-to-side vascular anastomosis procedures, including coronary artery bypass grafting (CABG).
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