Off-center Tissue Anchors with Spiral Coupling and Tension Members
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Solution Overview
Problem
Current tissue anchors face challenges in effectively anchoring elements like leads or sutures to soft tissue, such as cardiac tissue, due to limitations in their design and deployment mechanisms, which affect their stability and ability to distribute tension evenly.
Innovation Solution
The development of a tissue anchor system comprising a tissue-coupling element shaped as an open loop, typically a spiral, that is constrained by a deployment tool for delivery and then expands to provide a secure anchor, with a flexible elongate tension member to resist unwinding and distribute tension, allowing for greater load application and improved anchoring.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If the tissue anchor uses a conventional straight or simple loop design, then the deployment mechanism is simple, but the anchor cannot effectively resist unwinding and distribute tension evenly
Solution Approach 1:
The tissue-coupling element is configured as an open loop with a spiral or curved geometry instead of a straight design. This curvature provides mechanical resistance to unwinding forces while distributing tension along the curved path, enhancing anchor stability without requiring additional complex components
Solution Approach 2:
The open loop structure is divided into multiple segments or turns (spiral configuration) that work together to resist unwinding. Each segment contributes to the overall tension distribution, allowing the anchor to handle greater loads while maintaining a relatively simple single-piece construction
2Strength
If the tissue anchor applies greater loads to improve anchoring, then the anchoring strength increases, but the strain on the anchor site increases
Solution Approach 1:
The open loop configuration creates varying local tension distributions along its structure. The spiral or curved geometry allows different segments to bear different portions of the load, distributing the mechanical stress more evenly across the anchor site and reducing peak strain concentrations that could cause tissue damage
3Ease of operation
If the tension member is constrained during delivery to simplify deployment, then the delivery mechanism is simpler, but the natural tendency to straighten or unwind cannot be resisted
Solution Approach 1:
The tension member is pre-configured in a constrained state within the deployment tool before delivery. This preliminary constraint maintains the desired open loop or spiral configuration during delivery, and the tool is designed to release this constraint at the target site, allowing the pre-formed structure to engage the tissue without unwinding
Solution Approach 2:
The deployment tool acts as an intermediary that temporarily holds the tension member in its constrained configuration during delivery. This intermediary device protects the delicate open loop structure from premature unwinding while enabling precise delivery to the target site, where the constraint is then released
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This design enhances the stability and durability of the tissue anchor by resisting natural tendencies to straighten, enabling the application of greater loads and minimizing strain on the anchor site, thus providing a strong and secure coupling to the tissue.
Implementation Method 1
a flexible elongate tension member to resist unwinding and distribute tension
Data Source
Figure 1A~1B
Figure 1C~1D
Figure 2A~2B
AI summary
A tissue anchor (290, 420, 450, 470, 490) is provided including an anchor shaft (122); a tissue-coupling element (128), which (a) extends from a distal end (130) of the anchor shaft (122), (b) comprises a wire (150), and (c) is shaped as an open shape (291) when the tissue anchor (290, 420, 450, 470, 490) is unconstrained by a deployment tool (30); and a flexible elongate tension member (202), which (a) extends from a distal site (380) on the open shape (291), the distal site (380) located within 7 mm of a distal end (294) of the open shape (291), and (b) includes a proximal portion (208), which has a longitudinal segment (209) that runs alongside at least a portion (210) of the anchor shaft (122) when the tissue anchor (290, 420, 450, 470, 490) is unconstrained by the deployment tool (30). The tissue anchor (290, 420, 450, 470, 490) is configured to allow relative axial motion between the at least a portion (210) of the anchor shaft (122) and the longitudinal segment (209) of the proximal portion (208) of the flexible elongate tension member (202) when the tissue anchor (290, 420, 450, 470, 490) is unconstrained by the deployment tool (30).