Electrode Lead Anchoring via Coupling Member and Anchor
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Solution Overview
Problem
Medical devices such as electrode leads and catheters face challenges in secure anchoring within the body, particularly when a convenient anatomical structure is not available, leading to issues like dislodgement and ineffective therapy delivery, especially during minimally invasive procedures.
Innovation Solution
The use of a coupling member to tether the electrode lead or medical device to anatomical structures like skeletal structures, ligaments, or tendons, allowing for secure anchoring via anchors and adjustable coupling members that can be deployed using percutaneous techniques, enabling precise placement of electrodes near target tissues.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a percutaneous approach is used to implant the medical device, then the invasiveness of the procedure is reduced, but the ability to deploy large and complex anchoring mechanisms is compromised
Solution Approach 1:
The anchoring system is divided into separate components: an anchor element that can be deployed percutaneously through a needle or catheter, and a separate ligature sleeve or suture sleeve that is attached to the lead body. This segmentation allows the anchor to be inserted through a small incision while the larger ligature sleeve remains outside the body until needed for final securing.
Solution Approach 2:
The anchor element is designed to be deployable through a needle or catheter, effectively nesting the anchor within a delivery device that can pass through a small percutaneous incision. The anchor may be collapsed or compressed within the delivery device and then expanded or deployed at the target site.
2Ease of operation
If the lead is anchored to the superficial fascia using a ligature sleeve or suture sleeve, then the lead can be secured, but the incidence of lead dislodgement remains significant
Solution Approach 1:
An intermediate anchor element is introduced that can be securely implanted in stable anatomical structures such as bone or cartilage. The ligature sleeve or suture sleeve is then attached to this anchor, creating an intermediary connection point that distributes mechanical stress and prevents lead dislodgement while maintaining ease of operation during implantation.
3Ease of operation
If the lead is anchored to the superficial fascia, then the lead can be secured, but the distance between the superficial fascia and the target tissue of stimulation may be too great, causing tension on the lead body when patient posture changes
Solution Approach 1:
The anchor element serves as an intermediary that can be positioned at an optimal depth and location within stable anatomical structures closer to the target tissue. This intermediate positioning point allows the lead to be secured at the correct depth without excessive tension, while the ligature sleeve provides the external attachment point for surgical securing.
Data Source
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AI summary
Apparatus and methods for tethering an electrode lead to an anatomical structure within a patient using a coupling member are provided. An anchor configured to be secured to the anatomical structure and an electrode lead suitable for neuromuscular stimulation of spinal muscles and/or nerves innervating one or more muscles that contribute to spine stability may be used. The electrode lead is configured to be coupled to the anchor via the coupling member by securing a first end of the coupling member to the electrode lead and securing a second end of the coupling member to an eyelet of the anchor to place the electrode lead at a desired anatomical site within the patient.