Stapling Device Clip Guide for Heart Valve Fixation
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Solution Overview
Problem
Existing devices for attaching clips to tissue, particularly for heart valve repair, are complex, time-consuming, and lack stability, leading to difficulties in positioning clips accurately, especially during procedures involving a beating heart, and are not suitable for annuloplasty implants like helix rings, which can result in traumatic effects and increased patient risk.
Innovation Solution
A stapling device with a sheath and pusher unit that allows a clip to transition from a delivery shape to a relaxed shape through a single-step movement, providing improved stability and accuracy, and a clip design with legs that cross to securely fixate annuloplasty implants on either side of heart valve tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If complex devices with multiple movable parts are used to attach clips to tissue, then the clips can be secured with adequate fixation, but the procedure becomes more complicated and time-consuming
Solution Approach 1:
The device separates the clip holding function (anvil) from the release mechanism (pusher unit), allowing simple individual components to work together effectively. The anvil remains stationary while the pusher unit provides the releasing action, eliminating the need for complex movable parts in the anvil itself.
Solution Approach 2:
The clip is pre-formed into a delivery shape that is stable during insertion and positioning. The release mechanism is pre-positioned on the pusher unit, ready to actuate the clip from its delivery shape to its final deployed shape without requiring complex real-time adjustments.
2Reliability
If multiple operating steps with several movable parts are used, then adequate fixation can be achieved, but the procedure becomes more time-consuming
Solution Approach 1:
The device combines the clip holding function and the release mechanism into a single integrated system. The pusher unit integrates the releasing action with the delivery mechanism, allowing the operator to deploy the clip in a single continuous motion rather than through multiple separate steps.
Solution Approach 2:
The release mechanism is extracted as a separate pusher unit that acts on the anvil rather than being integrated into the anvil itself. This allows the anvil to remain simple and stationary while the pusher unit provides the necessary actuating force, reducing the number of moving parts that need to be coordinated.
3Reliability
If complex expensive devices are used, then adequate fixation can be achieved, but the advantage of using disposable single use devices is lost
Solution Approach 1:
The device is divided into two simple, manufacturable components: a stationary anvil and a disposable pusher unit. This segmentation allows the anvil to be a simple, reusable component while the pusher unit can be manufactured as a low-cost disposable item, maintaining the benefits of single-use devices without requiring complex mechanisms.
Solution Approach 2:
The pusher unit is designed as a disposable component that is discarded after a single use. This eliminates the need for complex, expensive reusable devices while ensuring sterility and reliability. The simple construction of the pusher unit makes it economically viable to manufacture as a single-use item.
4Ease of operation
If the clip position is not stable relative to the catheter, then the clip can be delivered easily, but the accuracy of attachment at the desired site is compromised
Solution Approach 1:
The clip is pre-formed into a stable delivery shape that maintains its position relative to the catheter during insertion and navigation. The anvil is designed with a specific geometry that holds the clip in a predetermined orientation, ensuring accurate positioning at the target site without requiring additional stabilization mechanisms.
5Ease of operation
If prior art devices are used for annuloplasty implants, then the procedure can be performed, but traumatic effects occur and long-term fixation is not ensured
Solution Approach 1:
The anvil is designed with a specific local geometry at its distal end that is optimized for annuloplasty implant fixation. The anvil surface includes features such as a recess or cavity that receives and secures the annuloplasty implant, distributing forces evenly and avoiding concentrated stress points that would cause tissue trauma.
Data Source
AI summary
A stapling device (100) for attaching a clip (205) to tissue is disclosed comprising a sheath (101) having a distal end (102) for delivery of said clip, a pusher unit (103, 103′) being movable inside said sheath along a longitudinal direction (104) of said sheath, said distal end comprising a clip guide (105, 105′) in which said clip is movable in said longitudinal direction, wherein said clip guide has a closed (G) configuration in which said clip guide is adapted to apply a restraining force on said clip so that said clip assumes a delivery shape (C), and an open (G′) configuration in which said clip assumes a relaxed shape (C′), wherein said pusher unit is movable from a proximal position (P) in which said clip guide is in said closed configuration, to a distal position (P′) in which said pusher unit engages said clip guide and the clip guide is in said open configuration. The clip guide comprises a first and a second clip guide arranged at radially opposite peripheries of the sheath and extending in the longitudinal direction.