Elastomeric Anchor With Non-Linear Lumen For Secure Lead Retention
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Solution Overview
Problem
Existing implantable medical device anchors face challenges in securely retaining therapy delivery elements due to insufficient or excessive gripping, and often cause damage to the leads during suturing.
Innovation Solution
An elastomeric anchor with a non-linear lumen that frictionally engages the therapy delivery element in a relaxed state, which can be converted to a linear lumen by stretching, allowing for compressive engagement and secure placement, and can be easily repositioned by returning to the relaxed state.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the anchor is made from elastic material to provide radially compressive force, then the anchor can secure the lead, but the anchor may cause damage to the implantable lead during suturing
Solution Approach 1:
The anchor is designed with a deformable body that can transition between a compressed configuration (for insertion) and an expanded configuration (for securing the lead). This dynamic transformation allows the anchor to be inserted without damaging the lead, then expand to provide securement force after insertion is complete
Solution Approach 2:
The anchor is pre-compressed within a delivery device before insertion, allowing it to be delivered through the lead without causing damage. After insertion, the anchor is released from the compressed state to expand and engage the lead, providing securement without the need for damaging suturing operations
2Reliability
If the anchor provides strong gripping force, then the lead retention is improved, but the anchor may cause excessive gripping and damage to the implantable lead
Solution Approach 1:
The anchor utilizes changes in physical parameters (compression and expansion of the elastomeric body) to control the gripping force. When compressed, the anchor has reduced diameter for insertion; when expanded, it provides optimal gripping force within safe limits, preventing both insufficient retention and excessive gripping damage
3Reliability
If the anchor is sutured to subcutaneous tissue to secure the lead, then the lead position is stabilized, but the suturing process may cause damage to the implantable lead
Solution Approach 1:
The suturing operation is extracted and replaced by an alternative retention mechanism. The anchor's expanded body provides friction-based retention and mechanical interlocking with the lead through its geometry, eliminating the need for sutures that could damage the lead during the suturing process
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 provides a strong holding force while minimizing lead damage and allowing for precise placement and repositioning of the therapy delivery elements, enhancing the stability and efficacy of implantable medical devices.
Implementation Method 1
The non-linear lumen of the relaxed state frictionally engages the outer surface of the therapy delivery element
Implementation Method 2
The elastomeric body portion of the anchor is stretched to convert a relaxed non-linear lumen to a stretched linear lumen
Data Source
AI summary
In some examples, an anchor for a therapy delivery element includes a body portion including a lumen extending through the body portion. The body portion includes a first configuration in which the lumen is linear, the body portion in the first configuration being configured to receive the therapy delivery element within the lumen. The body portion also includes a second configuration in which the lumen is non-linear, wherein the lumen of the body portion in the second configuration frictionally engages the therapy delivery element.