Tissue Anchor and Tether System for Gastrointestinal Implant Fixation
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Solution Overview
Problem
Gastrointestinal sleeves and implants face challenges in maintaining their position within the gastrointestinal tract due to muscular contractions and exposure to stomach acids and gas bubbles, leading to potential displacement and migration.
Innovation Solution
The use of tissue anchors, such as anchor pairs placed in gastric tissue and connected by tethers, provides a fixation mechanism to secure the implant in place, with various attachment methods including loops, clasps, and suture configurations to prevent migration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If tissue anchors and tethers are used to secure the gastrointestinal implant, then the implant stability is improved, but the device complexity increases
Solution Approach 1:
The anchoring system is divided into separate components: tissue anchors that are implanted into the gastric wall and tethers that connect the anchors to the gastrointestinal implant. This segmentation allows each component to perform its specific function independently, providing reliable fixation while maintaining ease of implantation through modular assembly.
Solution Approach 2:
The tether is threaded through a delivery catheter during implantation, with the catheter providing a conduit for the tether to pass through. The tissue anchors are deployed from the catheter tip, and the entire assembly is nested within the delivery system during the implantation process, simplifying the surgical procedure despite the complexity of the final anchored structure.
2Strength
If multiple anchor pairs are used to prevent implant migration, then the fixation strength is improved, but the difficulty of implantation increases
Solution Approach 1:
Multiple tissue anchors are connected by a single tether that is threaded through all anchors and attached to the gastrointestinal implant. This merging of multiple anchors into a single connected system provides cumulative fixation strength from multiple anchor points while simplifying the implantation process, as the tether can be pulled through all anchors in sequence rather than requiring separate attachment procedures for each anchor.
Solution Approach 2:
The tether is pre-threaded through the delivery catheter before implantation, and the tissue anchors are positioned along the catheter path. During implantation, the anchors are deployed at predetermined locations, and the tether is subsequently pulled through all anchors to create the fixed connection. This preliminary preparation of the tether path enables efficient multi-anchor fixation without requiring complex real-time adjustments during surgery.
Data Source
Figure 1~3A
Figure 3B~6
Figure 7~9
AI summary
Apparatus for anchoring a gastrointestinal implant having a needle (42) for piercing a first tissue fold (90), the needle containing a first tissue anchor (54A) deployable out from the needle after piercing the first tissue fold. The needle also contains a second tissue anchor (54B) connected to the first tissue anchor to form a first tissue anchor pair (50) having a tissue anchor pair loop (52), with the second tissue anchor deployable out from the needle after the needle is withdrawn from the first tissue fold. Optionally, a clasp (100) is attached to a gastrointestinal implant (40) and the tissue anchor pair loop is engageable with the clasp. The gastrointestinal implant may have a tether (60) including a tether loop, with the gastrointestinal implant attached to the tissue anchor pair by positioning the tether loop between the tissue fold and first or second tissue anchor.