Tissue Anchor With Nested Needle Deployment
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Solution Overview
Problem
There is a need for an effective medical device and method to place and secure tissue anchors within the body, particularly for procedures addressing pelvic floor dysfunctions such as urinary incontinence and prolapse conditions, where existing fixation devices may not adequately support various bodily implants.
Innovation Solution
A medical device comprising an elongate member, first and second needles, and a tissue anchor with arm portions and a base, where the needles are configured to receive and deploy the anchor within bodily tissue, allowing for secure coupling of implants to tissue using sutures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional fixation devices are used to secure implants in pelvic floor procedures, then the implants can be supported, but the devices lack precision in placement and adjustability in positioning
Solution Approach 1:
The tissue anchor is nested within the delivery device, with the anchor member contained inside the delivery device's lumen during insertion. The delivery device acts as a container that guides and positions the anchor precisely, then allows the anchor to be deployed outward. This nesting approach enables precise placement through the delivery device's guided path while maintaining a relatively simple overall device structure.
Solution Approach 2:
The tissue anchor features movable arm portions that can transition from a compressed state within the delivery device to an expanded state after deployment. This dynamic transformation allows the anchor to achieve secure fixation in tissue while being delivered through a narrow, simple delivery device. The arms can be positioned adjustably to accommodate different anatomical configurations.
2Adaptability or versatility
If existing tissue anchors are used, then fixation can be achieved, but the anchors lack multi-directional securing capability and adaptability to various tissue configurations
Solution Approach 1:
The tissue anchor is segmented into multiple independent arm portions (first arm portion and second arm portion) that can be positioned and secured independently. Each arm can engage tissue or implant structures at different locations and orientations, providing multi-directional securing capability. This segmentation allows the anchor to adapt to various tissue configurations while maintaining a straightforward deployment procedure through the delivery device.
Solution Approach 2:
The tissue anchor design provides multi-functionality by enabling fixation to different tissue structures and implant types through its multiple arm portions. The anchor can secure mesh implants, support pelvic organs, and adapt to various anatomical configurations, making it a universal solution for pelvic floor reconstruction procedures while being delivered through a single standardized delivery device.
3Reliability
If simple delivery devices are used to implant anchors, then the procedure is easier to perform, but the placement precision and security of fixation are insufficient
Solution Approach 1:
The delivery device is designed with pre-configured lumens and pathways that guide the anchor member to the precise deployment location before insertion. The device structure itself incorporates the positioning information, allowing the surgeon to simply advance the device to the target site and deploy the anchor without complex positioning maneuvers. This preliminary configuration of the delivery device ensures reliable fixation while maintaining operational simplicity.
Data Source
AI summary
In one embodiment, a medical device includes a tissue anchor, and elongate member, a first needle, and a second needle. The tissue anchor has a first arm portion, a second arm portion, and a base portion extending between the first arm portion and the second arm portion. The first needle extends from the elongate member. The first needle defines a lumen configured to receive the anchor member of the first arm portion of the tissue anchor. The second needle extends from the elongate member. The second needle defines a lumen configured to receive the anchor member of the second arm portion of the tissue anchor.