Visual Marker Lead Length Determination for Cardiac Implant Safety
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Solution Overview
Problem
Clinicians face challenges in determining the appropriate length of implantable medical leads to introduce into a patient's body, leading to potential dislodgement, tissue damage, and impaired therapy delivery due to insufficient or excessive lead length.
Innovation Solution
An implant tool system featuring a visual marker on the implantable medical lead or delivery catheter, indicating the minimum and additional lengths required for secure positioning, allowing clinicians to visually determine the correct lead length without fluoroscopic visualization, thereby reducing dislodgement and tissue damage risks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If visual markers are positioned on the implantable medical lead to indicate correct lead length, then the precision of lead length determination is improved, but the device complexity increases
Solution Approach 1:
Visual markers are pre-positioned on the implantable medical lead at specific distances from the distal end during manufacturing. These markers indicate the correct lead length to be introduced into the patient's body before the actual implantation procedure occurs, eliminating the need for complex intraoperative measurements and calculations.
Solution Approach 2:
The patent employs visual markers that may utilize color changes or distinct visual characteristics to indicate different lead length thresholds (minimum length, additional length). This allows clinicians to quickly identify the correct lead length through visual inspection rather than complex measurements, improving precision while keeping the device relatively simple.
2Measurement precision
If fluoroscopic visualization is used to determine lead length, then the measurement precision is improved, but the harmful factors increase due to radiation exposure
Solution Approach 1:
The patent replaces the mechanical/radiological imaging system (fluoroscopy) with a simple visual marker system. The markers are designed to be visible through the skin or with minimal imaging, allowing clinicians to determine lead length through direct visual inspection or simple surface markings, thereby eliminating or significantly reducing the need for fluoroscopic radiation exposure.
Solution Approach 2:
Visual markers serve as an intermediary between the implantable lead and the clinician's visual system. These markers translate the abstract concept of correct lead length into tangible visual cues that can be observed without radiation, mediating the measurement process in a safe and effective manner.
3Ease of operation
If the lead length is not accurately determined, then the ease of operation is improved (simpler procedure), but the reliability deteriorates due to dislodgement and tissue damage risks
Solution Approach 1:
The correct lead length is predetermined and marked on the device before implantation. This preliminary action ensures that when the clinician performs the implantation procedure, they can simply follow the visual markers to achieve accurate lead positioning without complex calculations or measurements, maintaining both simplicity and reliability.
Solution Approach 2:
The implantable medical lead provides its own measurement guidance through integrated visual markers. The lead essentially measures and indicates its own correct implantation depth, eliminating the need for external measurement tools or complex procedural steps, thereby maintaining ease of operation while ensuring reliable positioning.
Data Source
AI summary
An implant tool system includes an implantable medical lead and a delivery catheter. The implantable medical lead is configured to be delivered through an access point on a body of a patient. The delivery catheter is configured to deliver the implantable medical lead along an implantation path in the body of the patient. A visual marker is positioned on a body of the implantable medical lead. The visual marker is positioned proximal a distal end of the implantable medical lead by a distance indicative of a length of lead to introduce into the body of the patient. The visual marker may be positioned such that introduction of the length of lead into the body of the patient provides lead slack that reduces the likelihood of one or more of dislodgment of the implantable medical lead from the implant point or damage to a tissue of the patient.