Retrievable Intrapericardial Lead with Releaseable Attachment
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Solution Overview
Problem
Intrapericardial leads are difficult to explant due to their complex attachment structures and the need for a method that allows for easy decoupling and retrieval without causing tissue impediment.
Innovation Solution
The design of a bifurcated intrapericardial lead with a releaseable attachment structure, including filaments, interference fits, setscrews, and magnetic couplings, allows for decoupling of the distal ends, enabling easy withdrawal by forming a narrow elongated arrangement that facilitates slipping through tissue during explantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If intrapericardial lead placement is used to avoid vascular system involvement, then patient safety and lead stability are improved, but lead explantation becomes difficult and complex
Solution Approach 1:
The lead is divided into separable components: a proximal portion that remains secured to the pericardium and a distal portion with electrodes that can be detached. The attachment structure includes a male member on one branch and a female opening on the other, allowing controlled separation during explantation while maintaining stability during operation
Solution Approach 2:
The attachment structure transitions from a fixed, secure connection during operation to a releasable connection during explantation. The male-female coupling mechanism allows the lead to be dynamically changed from a stable implanted state to a removable state, enabling easy explantation without requiring complete removal of all lead components
2Reliability
If a secure attachment structure is used to maintain electrode contact with heart tissue, then electrical stimulation reliability is improved, but retrieval procedure complexity increases
Solution Approach 1:
The attachment structure is segmented into discrete male and female coupling components located at the distal ends of separate lead branches. This segmentation allows the complex attachment function to be divided into simple, standardized components that are easy to manufacture and assemble, reducing overall device complexity while maintaining secure electrode contact
Solution Approach 2:
The male-female coupling structure acts as an intermediary mechanism between the lead body and the pericardial tissue. This intermediate attachment structure provides a standardized interface that simplifies both implantation and explantation procedures, reducing the complexity of direct tissue-lead connections while ensuring reliable electrode contact during operation
3Reliability
If the lead maintains a looped configuration for stable heart tissue contact, then electrotherapy delivery is improved, but lead removal through tissue becomes impedimented
Solution Approach 1:
The lead configuration is dynamically changed during explantation by decoupling the distal ends of the lead branches. This transforms the lead from a fixed looped configuration that provides stable tissue contact to an open, linear configuration that can be easily withdrawn through the implantation site, eliminating the removal impediment while maintaining contact stability during operation
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
The solution enables efficient and secure implantation while allowing for easy explantation, maintaining electrode stability and contact with heart tissue, and reducing the complexity of retrieval procedures.
Implementation Method 1
The attachment structure includes a magnetic coupling structure
Data Source
AI summary
Disclosed herein is an implantable lead configured to administer electrotherapy to a patient heart from an implantable pulse generator. The lead may include a lead body and an attachment structure. The lead body includes a bifurcated distal region including first and second lead body branches each terminating in a distal end. At least one of the first lead body branch or second lead body branch includes an electrode. The attachment structure couples together the distal ends of the first and second lead body branches. The attachment structure is configured to release such that the distal ends of the first and second lead body branches can decouple from each other.