Medical Implant Fixation Anchors with Cuff and Tissue Engagement
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Solution Overview
Problem
Current implantable medical devices face challenges in maintaining a stable and fixed position within the body due to the limitations of existing fixation anchors, which often require deformation during minimally invasive delivery and may not provide sufficient anchoring force to prevent migration.
Innovation Solution
The development of fixation anchors with a cuff and tissue engagement member configuration that allows for secure anchoring to tissue, including designs with cuffs that have a slip-fit relation to the elongate member and tissue engagement members that can penetrate or contact the tissue without penetrating, facilitating stable positioning and minimal resistance during deployment and expansion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If fixation anchors are designed to penetrate tissue for secure anchoring, then anchoring strength is improved, but tissue damage increases
Solution Approach 1:
The tissue engagement member transitions from a non-penetrating configuration during delivery to a tissue-penetrating configuration after deployment. This parameter change allows the anchor to minimize tissue damage during insertion while achieving secure anchoring through penetration after deployment, resolving the contradiction between anchoring strength and tissue damage.
2Stability of the object's composition
If fixation anchors are made rigid for stable positioning, then positioning stability is improved, but device complexity increases
Solution Approach 1:
The fixation anchor is segmented into distinct functional components: a cuff portion for engagement with the frame member and a tissue engagement member for anchoring to tissue. This segmentation allows each component to be optimized independently - the cuff provides flexibility for delivery while the tissue engagement member provides rigidity for stable positioning, reducing overall device complexity.
Solution Approach 2:
The fixation anchor incorporates dynamic characteristics through its ability to transition from a compressed delivery state to an expanded deployed state. The tissue engagement member can also transition between non-penetrating and penetrating configurations, allowing the device to adapt its mechanical properties during deployment while maintaining positioning stability once deployed.
3Strength
If fixation anchors require permanent deformation for deployment, then secure anchoring is achieved, but manufacturing precision requirements increase
Solution Approach 1:
The fixation anchor is pre-configured with the tissue engagement member in a non-penetrating state during manufacturing, allowing for simpler manufacturing processes with lower precision requirements. The tissue-penetrating configuration is achieved through preliminary deployment actions rather than requiring high-precision manufacturing of the penetrating state itself.
Data Source
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AI summary
An implantable medical device comprising a frame comprised of at least one elongate member; and a fixation member engaged with the at least one elongate member. The fixation member comprises a first cuff surrounding a perimeter of the at least one elongate member from between 30° to 360°; a second cuff surrounding the perimeter of the at least one elongate member from between 30° to 360°; a tissue engagement member extending from one of the first cuff and the second cuff and configured to anchor to tissue at an implant site to thereby hold the implantable medical device in a position at the implant site; and a cuff joining member connected at a first end to the first cuff and at a second end to the second cuff.