Implant Delivery Device with Flange Biasing for Sheet Grafts
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Solution Overview
Problem
Current medical devices for rotator cuff repair, particularly in arthroscopic surgery, face challenges in accurately inserting and positioning sheet-like implants, such as grafts, due to difficulties in managing the implant's unfurled configuration and secure placement over tendons and bones.
Innovation Solution
An implant delivery device with a handle and an outer shaft, featuring a fixed and movable flange member system that biases the implant into an unfurled configuration, allowing it to be inserted through a cannula and securely positioned at the surgical site, where the flange members support the implant until anchors can be used to secure it.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If a sheet-like implant is inserted through a small incision using conventional methods, then the incision size is minimized, but the implant cannot be properly unfurled and positioned in the desired configuration
Solution Approach 1:
The implant is nested within the delivery device during insertion through the small incision. The device contains the implant in a compact state, allowing it to pass through the limited access incision. Once positioned, the implant is deployed from the device into its unfurled configuration at the surgical site.
Solution Approach 2:
The delivery device transitions from a compact insertion state to an expanded deployment state. The device allows the implant to be inserted in a constrained configuration and then unfurled to the desired shape at the target location, dynamically changing its configuration to resolve the contradiction between small incision size and proper implant shaping.
2Manufacturing precision
If the implant is held in a constrained position during insertion, then it can be delivered through the delivery device, but it cannot be properly positioned and secured at the surgical site
Solution Approach 1:
The delivery device is segmented into distinct functional components: an implant holding portion for secure retention during insertion, and release mechanisms that allow the implant to be freed at the surgical site. This segmentation enables precise controlled delivery while facilitating easy positioning once the implant is deployed from the device.
Solution Approach 2:
The delivery device acts as an intermediary between the implant and the surgical site. It provides controlled support and positioning during insertion, then facilitates transfer of the implant to the target location where it can be secured with anchors. The device mediates the transition from constrained transport to free positioning.
3Shape
If the implant is delivered in an unfurled state, then it can be properly positioned over tendons and bones, but it cannot be inserted through a small incision
Solution Approach 1:
The implant is nested within the delivery device during insertion through the small incision. The device contains the implant in a compact state, allowing it to pass through the limited access incision. Once positioned, the implant is deployed from the device into its unfurled configuration at the surgical site.
Solution Approach 2:
The delivery device transitions from a compact insertion state to an expanded deployment state. The device allows the implant to be inserted in a constrained configuration and then unfurled to the desired shape at the target location, dynamically changing its configuration to resolve the contradiction between small incision size and proper implant shaping.
Data Source
AI summary
An implant delivery device may include a handle disposed at a proximal end of the implant delivery device and configured to be grasped by a user. The device may further include an outer shaft extending from the handle to a distal end of the implant delivery device. In addition, the implant delivery device may include an implant holding portion proximate the distal end of the implant delivery device, the implant holding portion being configured to retain a sheet-like implant during implantation of the implant. Further, the implant holding portion may be configured to receive the implant between a fixed implant supporting flange member and configured to support the implant on one side, and a movable implant supporting flange member. The fixed implant supporting flange member may include a pair of substantially triangular shaped wings extending from a centerline axis of the outer shaft.


