Anchor Sleeve With Pre-Formed Weaknesses for Lead Fixation
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Solution Overview
Problem
Existing anchor systems for implantable medical devices face challenges in securely fixing therapy delivery elements, such as leads or catheters, within the body, as they tend to migrate over time due to patient movement, requiring rapid and minimally invasive fixation methods to prevent displacement.
Innovation Solution
An anchor sleeve with a deformable outer sleeve and an inner sleeve featuring pre-formed locations of weakness, allowing for localized deformation when a suture material is applied, which compressively engages the therapy delivery element and secures it in place using a medical adhesive.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a suture sleeve with outer elastomeric sleeve and inner gripping structure is used, then the lead can be secured through radial compression by sutures, but the procedure is time-consuming and complex
Solution Approach 1:
The anchor is divided into an outer sleeve and an inner sleeve as separate components. The outer sleeve provides the structural framework with suture grooves, while the inner sleeve provides the gripping mechanism with locations of weakness. This segmentation allows each component to be optimized independently and simplifies the overall assembly process.
Solution Approach 2:
The inner sleeve is pre-formed with locations of weakness during manufacturing. These predetermined weak points enable the material to deform in a controlled manner when radial compression is applied, eliminating the need for complex real-time adjustment mechanisms during the surgical procedure.
2Reliability
If traditional anchors are used to prevent lead migration, then fixation is achieved, but the procedure requires significant time and surgical complexity
Solution Approach 1:
The inner sleeve material is selected to have specific deformability characteristics that enable it to automatically engage and grip the lead through localized deformation at the pre-formed locations of weakness. This self-gripping mechanism eliminates the need for complex adjustment procedures and reduces surgical time.
3Reliability
If the inner sleeve material is highly deformable to allow gripping, then secure engagement is achieved, but the structural integrity may be compromised
Solution Approach 1:
The inner sleeve is designed with locations of weakness at specific positions where deformation is needed for gripping, while other regions maintain full structural integrity. This creates a non-uniform material distribution where softness is localized to the gripping zones and strength is maintained in the connection and support regions.
Solution Approach 2:
The inner sleeve structure is segmented into beams connected at deflection regions. The beams provide structural strength while the deflection regions with pre-formed locations of weakness allow localized deformation for gripping. This segmentation separates the conflicting requirements of strength and deformability to different spatial locations.
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 anchor sleeve effectively secures therapy delivery elements by creating a strong grip through localized deformation of the inner sleeve, reducing the likelihood of migration and ensuring stable placement of the device within the body.
Implementation Method 1
The inner sleeve is made from a material that plastically or elastically deforms in response to the radially inward force
Implementation Method 2
The inner sleeve is made from a material that plastically or elastically deforms in response to the radially inward force
Implementation Method 3
The outer sleeve optionally includes one or more fill ports adapted to direct a medical adhesive to at least the primary lumen
Data Source
AI summary
An anchor sleeve for securing a therapy delivery element, such as a stimulation lead or catheter, within a living body, that includes an inner sleeve with pre-formed locations of weakness that facilitate localized deformation. The anchor includes a deformable outer sleeve with a primary lumen extending along an axis. The outer surface of the outer sleeve includes a plurality of suture grooves oriented generally concentric to the axis. The inner sleeve includes a plurality of beams connected at deflection regions arranged around a secondary lumen. The inner sleeve is located in the primary lumen adjacent to the suture grooves so that the secondary lumen is generally concentric with the primary lumen. A plurality of locations of weakness are preformed in each of the beams to facilitate localized deformation in response to a radially inward force applied around the suture grooves by a suture material.