VfA Cardiac Therapy Delivery System with Steerable Fixation Sheath
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Solution Overview
Problem
Current implantable medical devices, such as pacemakers and cardioverter-defibrillators, often require transvenous leads that may not adequately address cardiac conduction diseases or abnormalities, particularly in patients with AV dyssynchrony or tachycardia, as they lack the ability for precise ventricular-from-atrial (VfA) cardiac therapy.
Innovation Solution
A medical device delivery system that includes a fixation sheath with a steerable element and a flexible needle for precise implantation of a VfA device in the triangle of Koch region, allowing for synchronous pacing and dual-chamber pacing, using a tissue-piercing electrode to sense and deliver therapy directly to the left ventricle from the right atrium.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If transvenous leads are used for implantable medical devices, then the device can be implanted and provide basic pacing functionality, but the device cannot adequately address cardiac conduction diseases or abnormalities, particularly in patients with AV dyssynchrony or tachycardia
Solution Approach 1:
The patent divides the cardiac therapy function into separate modules: a pulse generator implanted in the left pectoral region and disposable leads that can be selectively configured. This segmentation allows the system to address different cardiac conduction abnormalities with appropriate electrode configurations without requiring a complete device replacement.
Solution Approach 2:
The pulse generator is designed to provide multiple pacing functions including right atrial pacing, left ventricular pacing, and dual-chamber pacing through a single implantable unit. The device can be configured with different lead arrangements to treat various cardiac conduction diseases, making it universally applicable to multiple patient needs.
2Measurement precision
If a fixation sheath with steerable element and flexible needle is used for precise implantation, then the device can be accurately positioned in the triangle of Koch region, but the implantation procedure becomes more complex
Solution Approach 1:
The fixation sheath is pre-formed with a steerable element that allows the operator to guide the sheath to the target site before needle insertion. This preliminary positioning capability ensures accurate placement in the triangle of Koch region while maintaining a relatively simple procedural workflow.
Solution Approach 2:
The flexible needle acts as an intermediary tool that passes through the fixation sheath to deliver the pulse generator to the precise implantation site. This intermediary mechanism enables accurate positioning without requiring complex surgical techniques.
3Reliability
If a tissue-piercing electrode is used to deliver therapy directly from the right atrium to the left ventricle, then synchronous pacing and dual-chamber pacing can be achieved, but the risk of tissue damage or complications increases
Solution Approach 1:
The leads containing the tissue-piercing electrodes are designed as disposable components that are sterilized and used for a single implantation procedure. This disposable design ensures high reliability for synchronous pacing while minimizing the risk of long-term tissue damage or infection, as the leads are removed after use or are single-use sterile components.
Solution Approach 2:
The tissue-piercing electrode rapidly penetrates the atrial wall to establish the electrode-tissue interface for pacing. This quick penetration minimizes the time the electrode is in contact with tissue, reducing the opportunity for tissue damage while achieving the therapeutic goal of direct left ventricular pacing from the right atrium.
Data Source
AI summary
Devices, systems, and methods deliver implantable medical devices for ventricular-from-atrial (VfA) cardiac therapy. A VfA device may be implanted in the right atrium (RA) with an electrode extending from the right atrium into the left ventricular myocardium. A flexible leed, or another probe, may be advanced to the potential implantation site and used to identify a precise location for implantation of a medical device, such as an electrode, leadlet, lead, or intracardiac device. Some methods may include locating a potential implantation site in the triangle of Koch region in the right atrium of a patient's heart; attaching a fixation sheath to the right-atrial endocardium in the potential implantation site; and implanting the medical device over a guide wire at the potential implantation site. An implantable medical device may include an intracardiac housing and a leadlet, which may be delivered by these methods.