Epicardial Pacemaker Electrode Implantation Catheter with Variable-Shape Stabilizer
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Solution Overview
Problem
The challenge lies in achieving a minimally invasive and stable implantation of an epicardial cardiac pacemaker electrode into the pericardial gap with precise angle control and secure anchoring in the epicardium/myocardium, given the narrow space and risk of tissue perforation.
Innovation Solution
A device with a distal fixation mechanism using a variable-shape element, such as an inflatable balloon or shape-memory alloy, allows for alignment and stabilization of the electrode at a specified angle, ensuring reproducible and secure anchoring by maintaining optimal implantation orientation and preventing lateral deflection during screwing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional screwing device is used to implant the electrode, then secure anchoring in the myocardium is achieved, but the device becomes too large and cannot be inserted through the narrow pericardial gap
Solution Approach 1:
The device is divided into separate functional components: a thin implantation catheter for access, a separate fixation mechanism (screw or anchor) for anchoring, and a delivery system that combines them only at the implantation site. This segmentation allows each component to be optimized independently - the catheter remains thin for pericardial access while the fixation mechanism provides secure anchoring.
Solution Approach 2:
The fixation mechanism and electrode are nested within the implantation catheter during delivery. The catheter acts as a delivery sheath that contains the larger fixation components, allowing them to pass through the narrow pericardial gap in a compressed state and then deploy at the implantation site.
2Volume of moving object
If the implantation catheter diameter is reduced for minimally invasive access, then pericardial gap access is enabled, but control over implantation angle and position is lost
Solution Approach 1:
The implantation catheter is pre-shaped with a specific curvature and angle configuration that guides the electrode to the desired implantation angle. The catheter's distal portion is pre-formed to engage the myocardium at the correct angle, eliminating the need for complex steering mechanisms during insertion.
Solution Approach 2:
A guide channel or engagement structure within the catheter acts as an intermediary that translates the insertion motion into precise angular positioning. This intermediate structure ensures that the electrode is delivered at the correct angle relative to the myocardium surface.
3Ease of operation
If the catheter is made flexible for navigation, then pericardial gap access is improved, but stability during electrode implantation is reduced
Solution Approach 1:
The catheter transitions from a flexible state during insertion to a stabilized state during implantation. The catheter may include expandable structures, self-expanding segments, or engagement features that activate upon reaching the implantation site, providing stability when needed while maintaining flexibility for navigation.
Solution Approach 2:
Different portions of the catheter have different mechanical properties - the proximal portion remains flexible for navigation, while the distal portion contains stiffer or expandable structures that provide stability during electrode deployment and anchoring in the myocardium.
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
This approach enables minimally invasive, stable, and reproducible implantation of the epicardial pacemaker electrode with defined penetration angle, reducing the risk of injury to surrounding tissues and ensuring effective cardiac stimulation.
Implementation Method 1
A device with a distal fixation mechanism using a variable-shape element, such as an inflatable balloon or shape-memory alloy
Implementation Method 2
A device with a distal fixation mechanism using a variable-shape element, such as an inflatable balloon or shape-memory alloy
Implementation Method 3
A device with a distal fixation mechanism using a variable-shape element, such as an inflatable balloon
Data Source
Figure 1
Figure 2~3
Figure 4~5
AI summary
The invention relates to a device for the transcutaneous implantation of an epicardial pacemaker electrode (5), which is guided in a tubular, flexible external catheter (2) of an implantation catheter (1) that can be inserted into the gap of the pericardium (Pkh). According to the invention, the distal end portion of the electrode (4) is connected to a shape-variable element (6) for aligning, in particular for adjusting the implantation angle, and for stabilizing, in particular for laterally stabilizing the electrode (5).