Implanted Lead Revision Using a Folded Flap Guidewire Lumen
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Solution Overview
Problem
Conventional lead revision and replacement procedures are invasive, complex, and risky, often requiring additional surgeries and exposing patients to increased complications and resource expenditure.
Innovation Solution
A lead wire device with a first aperture for a guidewire and a flap that folds around an implanted lead, forming lumens to facilitate the insertion of a new guidewire through an existing incision, allowing nearly simultaneous revision and replacement procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional lead extraction procedures are used, then the implanted lead can be removed, but the procedure is invasive, complex, and requires additional surgeries
Solution Approach 1:
The device nests multiple functional components within a single catheter structure: the laser fiber is contained within the catheter lumen, the injection port is integrated into the catheter body, and the entire assembly is introduced through a single venous access point. This nesting eliminates the need for separate surgical procedures for lead extraction, laser delivery, and contrast injection.
Solution Approach 2:
The catheter device performs multiple functions simultaneously: it serves as the access route for lead extraction, delivers laser energy for scar tissue ablation, provides a pathway for contrast injection to visualize the lead, and maintains structural support during the procedure. This multi-functionality consolidates what would traditionally require multiple separate devices and procedures into a single integrated system.
2Manufacturing precision
If multiple separate procedures are performed for lead revision, then each step can be performed with specialized equipment, but the duration of surgery is substantially lengthened
Solution Approach 1:
The patent merges lead extraction, laser delivery, and contrast injection into a single integrated catheter device that is introduced through one venous access point. This consolidation allows all procedures to be performed sequentially through the same access site without requiring multiple punctures or separate surgical incisions, thereby dramatically reducing the overall surgery duration while maintaining the precision of each individual function.
Solution Approach 2:
The catheter is pre-configured with the laser fiber and injection port in their proper positions before introduction into the patient. The laser fiber is already positioned at the distal end ready for immediate activation, and the injection port is pre-positioned for contrast delivery. This preliminary preparation eliminates setup time during the procedure and allows immediate execution of each function once the catheter is in place.
3Ease of operation
If additional incisions are made for lead replacement, then new guidewires can be introduced, but the patient is exposed to additional risks of infection and complications
Solution Approach 1:
The single catheter serves as a universal access route for multiple functions: lead extraction, laser delivery, contrast injection, and guidewire introduction. By consolidating these functions into one access point, the device eliminates the need for additional incisions or punctures that would otherwise be required for guidewire insertion, thereby reducing the patient's exposure to infection and other procedure-related complications.
4Productivity
If conventional procedures are used, then each step can be performed independently, but limited precious resources are expended that could be devoted to other patients
Solution Approach 1:
The patent merges multiple resource-intensive procedures (lead extraction, laser delivery, contrast injection) into a single integrated catheter system introduced through one venous access. This consolidation reduces the total number of surgical staff needed, minimizes the time the surgical suite is occupied, and reduces the consumption of disposable materials compared to performing each procedure separately, thereby improving overall resource efficiency and productivity.
Data Source
AI summary
Devices for revising and replacing an implanted device are disclosed, which include a first lumen having a neck portion, a first aperture that opens to the neck portion of the first lumen, and a flap having a top edge, a bottom edge, a second aperture, and first and second lateral edges extending between the top and bottom edges. The neck portion of the first lumen is configured to receive a new guidewire inserted through the first aperture. The lateral edges of the flap are folded around an implanted device to form a second lumen in the bottom portion of the device, and a new guidewire inserted into the first lumen through the first aperture. The devices allow for the successive and nearly simultaneous revision and replacement of an implanted device.