Trialing Lead with Sheath-Covered Fixation Member
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current medical device systems for treating obstructive sleep apnea (OSA) face challenges in effectively placing leads to deliver electrical stimulation therapy, particularly in securing the leads to tissue without causing infection or lead migration during the trialing and chronic phases.
Innovation Solution
The system employs an implantable medical lead with a fixation member that secures the lead to tissue, using a sheath to prevent tine deployment during the trialing period and then exposing the fixation members to anchor the lead after the trialing period, allowing for both trialing and chronic use in a single implantation procedure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the fixation member is deployed during the trialing period, then the lead is securely anchored to tissue, but the lead cannot be repositioned or removed if therapy is ineffective
Solution Approach 1:
The fixation member is prepared and positioned on the lead before implantation, but remains in a non-deployed, covered state during the trialing period. The sheath prevents premature deployment while allowing the lead to be placed and tested. When trialing is complete and therapy effectiveness is confirmed, the sheath is removed and the fixation member is deployed to securely anchor the lead for chronic use.
Solution Approach 2:
The sheath acts as an intermediary protective covering that temporarily prevents the fixation member from engaging with tissue during the trialing period. This intermediary structure allows the lead to be implanted and tested without immediate permanent anchoring, providing the flexibility to remove or reposition the lead if needed, while still enabling secure fixation when required.
2Ease of manufacture
If a separate trialing lead and chronic lead are used, then trialing and chronic therapy can be optimized independently, but the patient requires two separate implantation procedures
Solution Approach 1:
The patent combines the trialing lead and chronic lead into a single integrated lead structure. The lead includes both trialing functionality (with external connector for trial stimulator) and chronic therapy functionality (with fixation member for permanent anchoring) in one device. This allows the patient to receive both trialing and chronic therapy through a single implantation procedure, eliminating the need for separate procedures while maintaining the ability to optimize both phases.
Solution Approach 2:
The single lead is designed to perform multiple functions: it can be used for trialing therapy with an external stimulator and for chronic therapy with an implantable pulse generator. The lead structure accommodates both temporary and permanent use scenarios, providing universal applicability across different therapy phases without requiring separate specialized leads.
3Reliability
If the fixation member is exposed during implantation, then the lead can be securely anchored, but the risk of infection increases due to additional exposure and manipulation
Solution Approach 1:
The fixation member is prepared and positioned on the lead before implantation but remains covered and non-functional during the critical implantation and trialing phases. This preliminary positioning without deployment minimizes the time the fixation member is exposed to potential contaminants. The fixation member is only exposed and deployed after the lead is successfully implanted and therapy effectiveness is confirmed, reducing unnecessary exposure and manipulation.
Data Source
AI summary
In an example, the disclosure describes a system with a lead having a proximal end and a distal end and an elongated lead body. The lead has one or more electrodes. A fixation member is located on the elongated lead body and is configured to secure the lead to tissue within a patient. The fixation member is located on the lead so the fixation member is closer to the proximal end than the one or more electrodes of the lead. A trialing adaptor receives the proximal end of the lead and is removable when a trialing period is completed. A sheath encloses at least a portion of the lead and covers the fixation member. The sheath is configured to remain in place over the lead during the trialing period.