Multi-durometer Suture Anchor for Flexible Leads
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Solution Overview
Problem
Existing suture anchors for securing therapy delivery elements, such as stimulation leads or catheters, face challenges in maintaining a secure hold due to the elastomeric sleeve interfering with the compression of the insert, particularly as leads become more flexible, leading to reduced holding force and potential lead migration.
Innovation Solution
A suture anchor with an inner sleeve made of a compliant material having a first durometer and an anchor body with a second durometer less than the first, featuring exterior suture grooves for direct engagement of the suture material, which applies a radial compression force that spreads along a greater surface area of the therapy delivery element, utilizing a deformable insert and optional reinforcing structures to enhance fixation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a thick elastomeric sleeve is used in the suture anchor, then the lead is well protected and the anchor body is well formed, but the insert cannot fully close and the holding force is reduced
Solution Approach 1:
The inner sleeve is divided into two distinct layers: an outer layer made of stiffer elastomeric material for structural support and protection, and an inner layer made of softer elastomeric material that allows the insert to collapse fully. This segmentation enables each layer to perform its specific function without interfering with the other, resolving the contradiction between protection and compression capability.
Solution Approach 2:
Different regions of the inner sleeve have different durometer values tailored to their specific functions. The outer layer has higher durometer for structural integrity and protection, while the inner layer has lower durometer to permit insert collapse. This local differentiation of material properties allows the sleeve to simultaneously provide protection and enable full compression.
2Reliability
If the elastomeric sleeve is made of a single durometer material, then the manufacturing is simplified, but the sleeve either interferes with insert closure or does not provide adequate protection
Solution Approach 1:
The inner sleeve is constructed as a composite structure with two different elastomeric materials having different durometer values. The outer layer uses a stiffer material for protection while the inner layer uses a softer material to allow insert collapse. This composite approach resolves the contradiction by combining materials with complementary properties in a single integrated component.
3Object-affected harmful factors
If leads become more flexible to reduce trauma, then the leads are softer and more comfortable, but they neck down when stretched causing reduced holding force in resistance lock anchors
Solution Approach 1:
The inner sleeve is segmented into dual-layer construction with different durometer properties. The softer inner layer accommodates the necking down of flexible leads without compromising the collapse mechanism, while the outer layer maintains structural integrity. This segmentation allows the anchor to maintain holding force even when used with increasingly flexible leads.
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
The solution effectively secures therapy delivery elements by distributing the compressive force over a larger surface area, reducing the risk of lead migration and maintaining a strong hold even as leads become more flexible, thereby improving the stability and efficacy of therapy delivery systems.
Implementation Method 1
The suture material causes the outer elastomeric sleeve to compress the inner gripping structure, which then collapses onto and grips the lead
Implementation Method 2
The suture material applies a radial compression force that spreads along a greater surface area of the therapy delivery element
Data Source
AI summary
A suture anchor for securing a therapy delivery element in a desired location within a living body using a suture material. The suture anchor includes an inner sleeve with a primary lumen sized to receive the therapy delivery element. The inner sleeve includes a compliant material having a first durometer. An anchor body extends around at least a portion of the inner sleeve and includes a portion of the primary lumen. The anchor body includes a compliant material having a second durometer less than the first durometer. At least one exterior suture groove is located on the anchor body to receive the suture material. The exterior suture groove extends substantially to the inner sleeve so the suture material engages directly with the inner sleeve.