Recapturable External Left Atrial Appendage Clip With Adjustable Locking
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Solution Overview
Problem
Existing surgical methods for occluding the left atrial appendage (LAA) face challenges such as the need for precise placement of exclusion clips, difficulty in determining complete closure, requirement of separate stabilization instruments, and limitations in clip design that restrict size adaptation and cause tissue damage.
Innovation Solution
A recapturable external LAA exclusion clip system with a delivery device that allows for one-handed operation, provides positive indication of complete clip placement, minimizes the need for separate stabilization, and features a closed-loop design with adjustable clamping pressure, enabling recapture and repositioning of the clip.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a surgical clip is used to occlude the left atrial appendage, then the fluid passageway is closed off to prevent blood clot formation, but the clip cannot be recaptured or repositioned if placement is incorrect
Solution Approach 1:
The clip design incorporates a dynamic locking mechanism that allows transition between locked and unlocked states. The clip includes a body with engagement features that can be selectively engaged or disengaged from the delivery device, enabling recapture and repositioning while maintaining secure occlusion when locked
Solution Approach 2:
A delivery device serves as an intermediary tool that provides temporary support and control during clip placement. The delivery device includes a shaft with a handle and end effector that interfaces with the clip, allowing precise positioning and controlled release while enabling recapture if needed
2Manufacturing precision
If separate stabilization instruments are used to manipulate the LAA, then precise clip placement is achieved, but device complexity and procedural time increase
Solution Approach 1:
The delivery device combines multiple functions into a single instrument: it provides stabilization of the LAA, guides the clip to the precise location, and controls the clip's deployment. The end effector of the delivery device integrates these functions, eliminating the need for separate stabilization instruments
Solution Approach 2:
The delivery device is designed as a multi-functional tool that can stabilize the LAA, position the clip accurately, and control clip deployment. The handle and end effector configuration allows one operator to perform multiple actions that previously required separate instruments
3Ease of manufacture
If the clip design is fixed, then manufacturing is simplified, but the clip cannot adapt to different LAA sizes or cause tissue damage
Solution Approach 1:
The clip incorporates adjustable features that allow modification of its configuration during the procedure. The clip body can be adjusted to accommodate different LAA sizes, and the engagement features can be selectively activated or deactivated to control clamping pressure and prevent tissue damage
Data Source
AI summary
A recapturable external LAA exclusion clip system includes a clip including first and second clip struts, at least one of the struts having a connector interface including a first portion of a lock, and a delivery device including a handle and an end effector. The handle includes jaw and lock controls. The end effector is connected to the handle and includes a clevis and first and second jaws connected to the clevis and operatively connected to the jaw control to actively articulate at least one of the jaws with respect to the other. At least one of the jaws has a connector including a second portion of the lock operatively connected to the lock control to removably lock with the first portion of the lock. The first and second portions of the lock have a locked state that is unlockable upon actuation of the lock control.