Linear Staple Anastomosis Assembly for Fast, Flexible Lumen Joining
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Solution Overview
Problem
Existing methods for forming vascular anastomosis, such as hand sewing and devices like the Synovis® MCA microvascular coupling device, are time-consuming, require high surgical dexterity, are not adaptable to vessels over 5 mm in diameter, and do not allow for blood vessel expansion with every heartbeat.
Innovation Solution
A device comprising a staple receiving assembly and a staple dispensing assembly, with linear staples that include barbs for retention, and vacuum and pneumatic systems for efficient lumen attachment, allowing for rapid anastomosis formation without the need for high dexterity and accommodating vessel expansion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If hand sewing is used to form vascular anastomosis, then the anastomosis can be formed with standard surgical tools, but the procedure takes 45-60 minutes or longer, resulting in prolonged tissue ischemia time
Solution Approach 1:
The patent replaces the manual mechanical sewing process with an automated stapling system. The stapling device uses a mechanical stapler that fires staples through the vessel walls in a single motion, eliminating the need for multiple hand-sewn sutures and significantly reducing the time required to form the anastomosis while maintaining ease of operation through a simple loading and firing sequence.
Solution Approach 2:
The stapling device is designed to be self-contained with an integrated staple supply system. The device loads staples into the stapling chamber and automatically fires them through the vessel walls without requiring external surgical instruments or complex manual manipulation, thereby reducing procedural time while maintaining operational simplicity.
2Productivity
If the Synovis MCA microvascular coupling device is used, then the anastomosis can be formed faster, but the procedure requires high surgical dexterity to evert the blood vessels over the spikes
Solution Approach 1:
The patent replaces the complex manual eversion and spike-coupling mechanism with an automated stapling system. The stapling device uses a mechanical firing mechanism that automatically positions and fires staples through the vessel walls without requiring the surgeon to manually evert vessels or manipulate spikes, thereby maintaining high productivity while eliminating the need for high surgical dexterity.
Solution Approach 2:
The stapling device acts as an intermediary tool between the surgeon and the vessel coupling process. Instead of requiring direct manual manipulation of the vessel ends and spikes, the device provides a standardized interface where the surgeon simply loads the device and fires the staples, eliminating the need for high-level manual dexterity while maintaining efficient anastomosis formation.
3Strength
If rigid rings are used in the Synovis device, then the structural integrity is maintained, but the blood vessel cannot expand with every heartbeat
Solution Approach 1:
The patent employs flexible staples and a flexible stapling mechanism that allows the vessel walls to expand and contract naturally. The staples are designed to be flexible rather than rigid, enabling them to accommodate the dynamic movement of the vessel during cardiac cycles while maintaining sufficient structural integrity to hold the anastomosis together. This flexibility is achieved through the material properties of the staples and the design of the stapling chamber.
Solution Approach 2:
The patent changes the mechanical parameters of the coupling structure by using flexible staples with appropriate elasticity and compliance. The staples are designed with specific mechanical properties that allow them to deform with vessel expansion while maintaining sufficient holding strength. This parameter adjustment enables the anastomosis to adapt to physiological vessel movement without compromising structural integrity.
4Ease of manufacture
If existing coupling devices are used, then the anastomosis can be formed with standardized procedures, but the device cannot be adapted for vessels over 5 mm in diameter
Solution Approach 1:
The stapling device is designed with universal applicability across different vessel sizes. The stapling chamber and staple design are configured to accommodate vessels ranging from small to large diameters, including over 5 mm. The device provides standardized operation through a single loading and firing sequence while maintaining adaptability through adjustable stapling parameters and a universally designed staple system that can handle various vessel thicknesses and diameters.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The device enables quick anastomosis formation, reducing tissue ischemia time, is adaptable to various vessel diameters, and allows for blood vessel expansion, improving surgical efficiency and tissue health.
Implementation Method 1
a first internal vacuum passage fluidically coupled to a plurality of first suction openings on the bottom surface designed to be coupled to a vacuum source in order to retain the everted end of the first lumen to the bottom surface
Implementation Method 2
a second internal pressurized air passage fluidically coupled to the plurality of staple dispensing cavities and designed to be coupled to a pressurized air source in order to pneumatically propel the staples out of the plurality of staple dispensing cavities
Data Source
AI summary
A device for forming an anastomosis between two lumens may include a staple receiving assembly and a staple dispensing assembly. The staple receiving assembly may include a first body defining a bottom surface surrounding a first central opening and staple receiving cavities. The staple dispensing assembly may include a second body defining a top surface surrounding a second central opening and staple dispensing cavities. The device may also include a plurality of linear staples positioned within the staple dispensing cavities. The is designed to retain everted ends of the first and second lumens between the bottom surface and the top surface. Further, the staple dispensing assembly may propel the linear staples from the staple dispensing cavities through the retained everted ends of the first and second lumens toward the staple receiving cavities in order to form an anastomosis between the first lumen and the second lumen.