Pivotable Hinged Stapler Head for Minimally Invasive Heart Valve Repair
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Solution Overview
Problem
Current surgical stapling devices for minimally invasive heart surgery, particularly for repairing heart valves, face challenges in effectively applying staples while maintaining precise control and minimizing tissue remodeling, especially when operating on a beating heart.
Innovation Solution
A surgical stapler design featuring a hinged stapling head with a pivotable mechanism that allows staples to be inserted with their prongs oriented proximally, enabling force application parallel to the handle, and a mechanism for adjusting staple spacing to achieve precise tissue constriction, along with a reloadable magazine for continuous operation within the heart chamber.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If the hinge connection is positioned close to the handle, then the device can be made more compact for delivery, but the force application direction cannot be optimized for pulling the stapler head toward the user
Solution Approach 1:
The device is segmented into distinct functional modules: a handle assembly, a deliverable shaft, and a stapler head assembly that can be positioned independently. The hinge connection is strategically positioned at the distal end of the deliverable shaft, separating the force application function from the delivery function, allowing optimized force direction while maintaining deliverability.
Solution Approach 2:
The hinge connection is positioned at the distal end of the deliverable shaft, creating a lever arm that extends the force application distance from the handle. This dimensional extension allows the operator to apply force in a direction that pulls the stapler head toward the user, optimizing the force vector for effective tissue stapling.
2Ease of operation
If the stapler head is positioned far from the handle, then force can be applied parallel to the handle for better control, but the device becomes too large for effective delivery to the heart chamber
Solution Approach 1:
The device is divided into a proximal handle assembly and a distal stapler head assembly connected by a deliverable shaft. This segmentation allows the handle to remain compact for delivery while the stapler head can be positioned at the optimal distance for force application and control during the stapling procedure.
Solution Approach 2:
The deliverable shaft is designed to be extendable and retractable, transforming the device from a compact deliverable state to an extended operational state. During delivery, the shaft is retracted to minimize device size, and during operation, it is extended to provide the necessary lever arm for precise force application and control.
3Ease of manufacture
If staples are inserted with prongs directed away from the handle, then the insertion direction is simplified, but the staple prongs cannot be positioned closer to the user for optimal tissue constriction in apical entry procedures
Solution Approach 1:
Instead of directing staple prongs away from the handle as in conventional designs, this device inverts the orientation so that staple prongs point toward the handle. The stapler head is designed with an inverted staple carrier that holds and deploys staples with prongs oriented in the opposite direction, enabling optimal tissue constriction with apical entry.
Solution Approach 2:
The staple orientation is changed by rotating the staple carrier 180 degrees relative to conventional designs. This dimensional reorientation allows the staple prongs to point toward the handle, enabling the surgeon to apply force in the most effective direction for tissue constriction while maintaining a simple insertion mechanism.
4Device complexity
If the stapler uses non-interconnecting staples, then the stapling mechanism is simpler, but tissue remodeling occurs between staples reducing the effectiveness of valve repair
Solution Approach 1:
The device combines multiple interconnecting staples into a single integrated staple unit with multiple legs that can simultaneously engage multiple tissue points. This merging of multiple staple functions into one interconnected structure prevents tissue remodeling between staples while maintaining a relatively simple stapling mechanism that deploys the interconnecting structure in a single action.
Data Source
AI summary
A surgical stapler includes a control handle having a forward-extending barrel and a stapling device at the distal end of the barrel, where the stapling device has a stapling head part, a stapler body part, and a hinge connection therebetween such that the stapling head part is pivotable relative to the barrel. The stapling head part has a holder region, opposite the hinge connection, configured for holding a surgical staple during positioning and implanting the staple. The proximal end portion of the stapling head part can be pivoted outwardly relative to the barrel to at least about 15° from an at rest position, juxtaposed with the stapler body part, to an active position for implantation of a staple into tissue in a generally proximal direction toward the control handle.