Implantable Stimulation Lead Fixation Without Suturing Trauma
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Solution Overview
Problem
Existing implantable medical devices face challenges in achieving stable fixation within the body without requiring large incisions and complex suturing processes, which can lead to discomfort and increased surgical trauma.
Innovation Solution
The use of a non-conductive filament with fixation projections and an open-work member to secure the device, providing both acute and chronic fixation through tissue engagement and ingrowth, respectively.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional suturing methods are used to secure the implantable device, then stable fixation is achieved, but surgical trauma and complexity increase
Solution Approach 1:
The patent extracts the fixation function from the traditional suturing process by incorporating fixation projections directly onto the lead body and an open-work member with tissue engagement features. This eliminates the need for separate suturing materials and complex suturing procedures while maintaining reliable fixation stability.
Solution Approach 2:
The lead incorporates self-fixating features including fixation projections and an open-work member that automatically engage with tissue during implantation. The device performs its own fixation function without requiring external suturing intervention, thereby reducing surgical complexity while ensuring stable fixation.
2Reliability
If traditional suturing methods are used to secure the implantable device, then stable fixation is achieved, but patient discomfort increases
Solution Approach 1:
The patent removes the harmful element of complex suturing by integrating fixation projections and an open-work member directly onto the lead. This extraction of the suturing function eliminates the need for additional suturing materials and procedures that cause surgical trauma and patient discomfort.
Solution Approach 2:
The lead's self-fixating mechanism with integrated projections and open-work member provides stable fixation without requiring external suturing. This self-service approach minimizes surgical intervention and reduces the harmful effects of surgical trauma on the patient.
3Reliability
If a non-conductive filament with fixation projections is used, then acute fixation is provided, but long-term chronic fixation may be insufficient
Solution Approach 1:
The patent merges two fixation mechanisms into a single integrated system: the non-conductive filament with fixation projections provides immediate acute fixation, while the open-work member with its tissue-engaging structure provides long-term chronic fixation through tissue ingrowth. The combination of these two features ensures both acute and chronic fixation reliability.
Solution Approach 2:
The lead employs a composite fixation structure combining the non-conductive filament material with the open-work member structure. This composite approach integrates materials and structures with different functional properties - the filament provides immediate mechanical anchoring while the open-work member facilitates long-term tissue integration, ensuring both acute and chronic fixation.
4Reliability
If the open-work member extends proximally from the secured filament, then additional fixation support is provided, but device complexity increases
Solution Approach 1:
The patent merges the open-work member with the lead body structure, allowing it to extend proximally from the secured filament location. This integration provides additional fixation support along the lead length without requiring separate components, thereby reducing overall device complexity while enhancing fixation reliability.
Data Source
Figure 1
Figure 2~3B
Figure 4A
AI summary
An implantable medical system comprising an implantable stimulation device; and an implantable stimulation lead (300, 400, 500), the device and lead being adapted for coupling to one another, the lead (300, 400, 500) comprising, an elongate insulative body (350, 450) including a proximal segment (353), a distal segment (351), and a pre-formed bend (352) extending therebetween, a stimulation electrode circuit, at least one sense electrode circuit, the stimulation and sense electrode circuits being supported by the insulative body (350), the distal segment (351) of the insulative body (350) having electrodes of the stimulation electrode circuit and the at least one sense electrode circuit mounted thereabout, and a non-conductive filament (200) including a plurality of fixation projections (205), wherein the filament, including the fixation projections (205), extends along a length of an outer surface of the pre-formed bend (352) and distal segment (351) of the insulative body, the filament (200) being wound about all or a portion of the length with an open pitch and being secured to the outer surface (355, 455) such that the projections (205) thereof protrude outward from the outer surface (355, 455) and are spaced apart from one another along the length of the outer surface (355, 455).