Flat Self-Tunneling Lead for Introducer-Free Subcutaneous Implantation
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Solution Overview
Problem
The implantation of medical leads through subcutaneous tissue is time-consuming and invasive due to the use of introducers, which create larger tunnels than the lead, allowing for potential migration and less secure placement.
Innovation Solution
Implantable medical leads with a generally flat or planar distal end portion that is sufficiently stiff to be pushed through subcutaneous tissue without an introducer, utilizing materials with high modulus of elasticity and potentially softening after implantation to conform to the tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If an introducer is used to tunnel subcutaneous tissue, then the lead can be implanted, but the procedure becomes time-consuming and invasive
Solution Approach 1:
The patent removes the introducer from the implantation system, allowing the lead to be implanted directly through the tissue without requiring a separate tunneling device. This extraction of the introducer eliminates the time-consuming and invasive nature of the traditional two-step process while maintaining the ability to successfully implant the lead.
Solution Approach 2:
Instead of using an introducer to create a tunnel first and then passing the lead through it, the patent inverts the approach by having the lead itself create its own path through the tissue. The lead is pushed directly through the subcutaneous tissue without pre-formed tunnel, reversing the traditional sequence of operations.
2Ease of operation
If an introducer is used to create a tunnel, then the lead can be passed through, but the tunnel is larger than the lead allowing potential migration
Solution Approach 1:
By removing the introducer from the system, the patent eliminates the size mismatch between the introducer-created tunnel and the lead. Without an introducer, there is no oversized tunnel, thus preventing lead migration while maintaining ease of passage.
Solution Approach 2:
The patent inverts the traditional approach by having the lead create its own path rather than passing through a pre-formed tunnel. This ensures the tunnel size matches the lead dimensions exactly, eliminating the migration problem caused by oversized tunnels while still allowing smooth passage.
3Ease of operation
If a traditional lead is used with an introducer, then implantation is possible, but tissue erosion and patient discomfort increase
Solution Approach 1:
The patent removes the introducer, which is the source of tissue trauma during insertion and removal. By eliminating this external device that requires forceful insertion and extraction, the method reduces tissue erosion and associated patient discomfort while maintaining implantation capability.
Solution Approach 2:
Instead of forcing a lead through an introducer tunnel, the patent inverts the approach by having the lead directly push through the tissue with its own structural integrity. This direct path creation minimizes tissue disruption and erosion compared to the traditional method of forcing equipment through a pre-formed tunnel.
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
Facilitates secure and efficient lead placement with reduced migration, minimizing tissue erosion and improving patient comfort by creating tunnels that match the lead's dimensions, thus enhancing the stability and effectiveness of electrical stimulation therapies.
Implementation Method 1
The distal end portion is generally flat or planar and sufficiently stiff to be pushed through subcutaneous tissue
Data Source
AI summary
An implantable medical lead includes (i) a proximal end portion including a contact and having a proximal end; and (ii) a distal end portion including an electrode and having a distal end. The electrode is electrically coupled to the contact. The distal end portion is generally flat and sufficiently stiff to be pushed through subcutaneous tissue.