Extraction Device Cutting Tissue Ingrowth for Leadless Pacemaker Removal
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Solution Overview
Problem
Chronically implanted medical devices like leadless cardiac pacemakers face complications during removal due to substantial tissue growth, which existing extraction tools struggle to effectively cut or remove, hindering successful retrieval.
Innovation Solution
The development of extraction devices equipped with retrieval loops and other tools that can cut or tear through ingrowth tissue to expose and grasp the implanted device's retrieval feature, allowing for its safe removal, featuring abrasive or cutting surfaces and the ability to conduct RF energy for enhanced tissue cutting.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If extraction devices are designed to remove chronically implanted devices, then device retrieval capability is improved, but tissue growth around the implanted device complicates removal
Solution Approach 1:
The extraction device performs preliminary cutting and tearing actions on the tissue growth before grasping the implanted device. The cutting element is advanced to cut through encapsulating tissue, and the tearing element is advanced to tear away adhering tissue, exposing the retrieval feature before actual device extraction occurs.
Solution Approach 2:
The extraction device extracts the harmful tissue growth from between the retrieval tool and the implanted device. By cutting and tearing away the tissue growth, the device removes the obstruction that prevents successful retrieval, allowing the retrieval feature to be accessed and grasped.
2Ease of operation
If cutting elements are added to extraction devices, then tissue cutting capability is improved, but device complexity increases
Solution Approach 1:
The extraction device combines multiple functions into a single integrated tool. The same device includes both cutting capability (via the cutting element) and grasping capability (via the retrieval loop), allowing one device to perform multiple steps of the extraction process rather than requiring separate tools.
Solution Approach 2:
The cutting element and tearing element are nested within or integrated with the retrieval loop structure. The cutting element can be advanced through the retrieval loop, and both elements work in conjunction with the retrieval feature, creating a compact multi-functional device.
3Ease of operation
If RF energy conduction is implemented for tissue cutting, then cutting effectiveness is improved, but energy requirements increase
Solution Approach 1:
The patent replaces purely mechanical cutting (which would require significant force and potentially more complex mechanical mechanisms) with RF energy-based cutting. The RF cutting element uses electromagnetic energy to cut tissue, which can be more effective and cleaner than mechanical cutting methods.
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 efficient and effective removal of chronically implanted devices by cutting through ingrowth tissue to expose and retrieve the device, minimizing tissue damage and facilitating successful extraction.
Implementation Method 1
The retrieval loop may be configured to cut or tear through at least some of the tissue ingrowth that extends over the LCP in order to expose the retrieval feature of the LCP
Implementation Method 2
the first surface may include an abrasive material and the second surface may not include the abrasive material
Implementation Method 3
the first surface may include a cutting edge and the second surface may be smooth
Implementation Method 4
The retrieval loop may also be configured to grasp the exposed retrieval feature and pull the LCP into the retrieval cavity of the extraction device
Implementation Method 5
An extractor member may be extendable beyond the retrieval cavity and may be configured to cut through ingrowth tissue that extends over the LCP in order to expose the retrieval feature of the LCP
Implementation Method 6
the extractor member may include a hollow needle that is fluidly coupled with a fluid source in order to inject a fluid in a space between the implanted leadless cardiac pacemaker and the ingrowth tissue
Implementation Method 7
the extraction device may include a preshaped cutting stylet that is extendable through the hollow needle and under the ingrown tissue in order to cut through the ingrowth tissue
Implementation Method 8
the extractor member may include a deflectable probe that is configured to pierce and cut through the ingrowth tissue
Implementation Method 9
the extractor member may include a grasping forceps configured to grasp and tear at the ingrowth tissue
Implementation Method 10
at least a portion of the inside surface of the retrieval loop may be electrically exposed to conduct RF energy to cut through the ingrowth tissue
Data Source
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AI summary
Extraction devices for extracting chronically implanted devices such as leadless cardiac pacemakers (LCP). In some cases, the extraction devices may be configured to cut or tear through at least some of the tissue ingrowth around and/or over the chronically implanted device such that a retrieval feature on the chronically implanted device may be grasped for removal of the chronically implanted device.