Biodegradable Suture Line for Secure Cardiac Lead Placement
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Solution Overview
Problem
Implantable electrical stimulation leads often require invasive surgery for removal and can cause unwanted tissue damage due to dislodgment or shifting within the heart, leading to inaccurate sensing and unreliable cardiac pacing therapy.
Innovation Solution
The development of an electrical stimulation lead with a biodegradable suture line and a flexible helical electrode that actively engages tissue, allowing for secure placement and removal without invasive surgery, using a barbed structure to prevent dislodgment and a coaxial connection interface for stable electrical communication.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional epicardial wires and leads are used, then electrical stimulation function is achieved, but removal requires invasive surgery and may cause tissue damage
Solution Approach 1:
The lead system is divided into two separate components: a removable lead body and a permanent suture line embedded in the tissue. This segmentation allows the lead body to be easily extracted without requiring invasive surgery, while the suture line remains in place to maintain electrical connection. The separation of removal function (lead body) from permanent anchoring (suture line) resolves the contradiction between easy removal and preventing tissue damage.
Solution Approach 2:
The suture line is extracted as a separate permanent component that remains embedded in the tissue, while the lead body can be completely removed. This extraction of the anchoring function from the removable component allows non-invasive removal of the lead body without compromising the permanent electrical connection pathway through the tissue.
2Reliability
If conventional epicardial wires and leads are used, then electrical stimulation function is achieved, but the leads may become dislodged or shift within the heart
Solution Approach 1:
The suture line is preliminarily embedded in the tissue during the initial procedure to create a permanent anchoring structure before the lead body is fully deployed. This preliminary action ensures that the lead cannot become dislodged or shift within the heart, as the suture line provides continuous mechanical anchoring from the outset.
Solution Approach 2:
The suture line acts as an intermediary between the lead body and the heart tissue. It serves as a permanent mechanical bridge that prevents dislodgment of the lead body while allowing for easy removal of the lead body itself. The suture line mediates the connection between the removable lead and the permanent tissue anchoring.
3Ease of operation
If a biodegradable suture line is used, then non-invasive removal is enabled, but the suture line must degrade within a specific time frame
Solution Approach 1:
The suture line material parameters are specifically selected to achieve degradation within 5 to 180 days, matching the expected duration of the lead body implantation. This parameter optimization ensures that the suture line degrades at the appropriate time to facilitate non-invasive removal, while maintaining structural integrity throughout the therapeutic period.
Solution Approach 2:
The suture line is designed as a temporary, biodegradable component that performs its anchoring function for the duration of the lead body implantation and then degrades to facilitate removal. This disposable-like approach applies to the suture line, which is intentionally designed to be short-lived compared to the lead body, enabling non-invasive removal after serving its temporary anchoring purpose.
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 secure placement and removal of the electrical stimulation lead, reducing the risk of tissue damage and ensuring reliable cardiac pacing therapy, with the biodegradable suture line degrading within 5 to 180 days to facilitate non-invasive extraction.
Implementation Method 1
The suture line is a biodegradable suture line that includes glycolide, dioxanone, trimethylene carbonate, glycolic acid, polymers thereof, copolymers thereof, or combinations thereof. In some embodiments the suture line is configured to degrade within five to 180 days.
Data Source
AI summary
An electrical stimulation lead includes a lead body having a proximal end and a distal end. A connection interface is coupled to proximal end and a tip electrode is coupled to the distal end. The tip electrode is in electrical communication with the connection interface. A suture line having a barbed structure extends from the tip electrodes. In some examples, the electrical stimulation lead includes a flexible helical electrode capable of engaging tissue. In some examples, the suture line is biodegradable. A method for using an electrical stimulation lead. The method includes placing a tip electrode in a first tissue by pulling the tip electrode into place using a suture line that has a barbed the structure. The method further includes applying electrical stimulation therapy and extracting the tip electrode.