Electrode Lead With Variable Length Fixation Device
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Solution Overview
Problem
Existing electrode leads for cardiac resynchronization therapy (CRT) face challenges in secure fixation within the coronary sinus, with previous methods being either non-reversible, traumatic, or unreliable due to dependence on vein geometry, limited expansion force, and difficulty in repositioning.
Innovation Solution
A long, stretched-out electrode lead with a variably extendable fixation device that can be adjusted along the longitudinal axis, allowing for optimal electrode positioning and secure fixation in the coronary sinus, featuring a preformed helix that can be extended and retracted for adjustable length and secure anchoring.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a wedge position fixation method is used, then the electrode lead can be fixed in the vessel, but the final position is determined by vein geometry rather than optimal therapy location
Solution Approach 1:
The fixation device is designed with a dynamically adjustable length that can be varied between retracted and extended states. This allows the operator to optimize both the fixation security and the electrode position according to the specific anatomical conditions and therapy requirements, rather than being constrained by fixed geometry.
Solution Approach 2:
The length parameter of the fixation device is made variable through a controlled extension mechanism. By changing the extension length parameter, the system can adapt to different vein geometries while maintaining optimal electrode positioning for therapy, resolving the contradiction between fixation reliability and position adaptability.
2Reliability
If an expandable stent fixation device is used, then the lead body is clamped securely in position, but the fixation becomes non-reversible making it difficult to move or remove the electrode lead
Solution Approach 1:
The fixation device employs a dynamic extension mechanism that allows reversible adjustment between retracted and extended states. This dynamic capability enables secure fixation when extended while maintaining the ability to retract and move the electrode lead if needed, unlike irreversible expandable stents.
Solution Approach 2:
The fixation device includes self-contained extension and retraction capabilities through integrated mechanical means (such as screw mechanisms or spring-loaded systems). This self-service design allows the operator to control the fixation state without external assistance, enabling both secure anchoring and easy relocation as clinically required.
3Ease of repair
If wire helices are used for fixation, then the device can be reversibly extended and withdrawn, but the small diameter and limited tension force result in unreliable fixation
Solution Approach 1:
The fixation device is designed with variable length capability that allows optimization of the contact surface area and tension force parameters. By extending the fixation device to an appropriate length, the system achieves sufficient contact area with the vascular wall to provide reliable fixation while maintaining reversibility through controlled retraction.
Solution Approach 2:
Instead of relying solely on small-diameter wire helices, the invention extends the fixation structure along the longitudinal dimension of the vessel. This dimensional change provides increased surface area for contact and distribution of fixation force, improving reliability while preserving reversibility.
4Adaptability or versatility
If wires are used to fix the electrode lead, then the device can be moved to different places, but the wires cut into the vascular wall causing trauma
Solution Approach 1:
The fixation device uses a flexible, biocompatible structure that distributes contact pressure along its length rather than concentrating force at discrete wire contact points. This flexible design reduces mechanical trauma to the vascular wall while maintaining position adjustability through reversible extension and retraction.
Solution Approach 2:
By varying the extension length parameter of the fixation device, the system can optimize the distribution of contact pressure along the vascular wall. This parameter adjustment allows secure fixation with minimal trauma, avoiding the cutting action caused by rigid wire structures.
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
Enables optimal electrode placement and secure fixation under varying anatomical conditions, reducing the need for multiple electrodes and allowing for repositioning, thus improving the reliability and efficiency of CRT therapy.
Implementation Method 1
a fixation device (20) to fix the electrode lead (1) in a blood vessel, which is extendable out of the lead body (10), in particular extendable in the direction of the longitudinal axis (L)
Implementation Method 2
featuring a preformed helix that can be extended and retracted for precise placement and minimally invasive procedures
Data Source
AI summary
An electrode lead for the coronary sinus, with a lead body that has a distal section for insertion into the coronary sinus, and at least one electrode to make contact with body tissue, the at least one electrode being arranged on the distal section of the lead body. The electrode lead has a fixation device that can be extended out of the lead body to fix the electrode lead in a blood vessel.