Nested Sheath Intravascular Delivery for Precise IMD Placement
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Solution Overview
Problem
Current methods for the intravascular deployment of implantable medical devices (IMDs) are invasive and lack efficient techniques for remote deployment, particularly in navigating complex vascular anatomy and ensuring precise placement.
Innovation Solution
The use of a kit and method involving an elongated outer sheath and inner sheath system with various configurations, including inflatable members, tapered ends, and deployment receptacles, to facilitate the intravascular implantation of IMDs, allowing for precise alignment and deployment of devices within the vasculature while minimizing invasiveness.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If current methods for intravascular deployment of IMDs are used, then the procedure can be completed, but the invasiveness is high and navigation through complex vascular anatomy is difficult
Solution Approach 1:
The patent employs a nested sheath configuration where an inner sheath is positioned within an outer sheath. The inner sheath has a distal end that can be positioned at a target site while the outer sheath provides structural support during navigation. This nested arrangement allows the device to navigate complex vascular anatomy using the outer sheath while enabling less invasive deployment through the inner sheath at the destination.
Solution Approach 2:
The delivery system is divided into separate functional components: an outer sheath for navigation and structural support, and an inner sheath for precise device deployment. This segmentation allows each component to be optimized for its specific function, improving overall ease of operation while reducing the invasiveness of the overall procedure.
2Object-affected harmful factors
If remote deployment techniques are implemented, then invasiveness is reduced, but precise placement and alignment become more challenging
Solution Approach 1:
The inner sheath is slidably received within the outer sheath, allowing the inner sheath to be advanced to a precise target location while the outer sheath remains positioned for structural support. This nested configuration enables accurate alignment of the IMD at the distal end of the inner sheath while maintaining the benefits of reduced invasiveness through remote deployment.
Solution Approach 2:
The patent employs coupling modules with mating features that replace complex mechanical alignment systems. The first coupling module on the inner sheath connects to a mating coupling module on the outer sheath, providing precise alignment through simplified mechanical interfaces that reduce the complexity of remote positioning while maintaining accuracy.
3Measurement precision
If coupling modules are used to connect inner and outer sheaths, then axial alignment is improved, but device complexity increases
Solution Approach 1:
The coupling modules serve multiple functions: they provide axial alignment between the inner and outer sheaths, enable relative movement between the sheaths during deployment, and maintain structural integrity of the assembled device. By consolidating these functions into integrated coupling modules with mating features, the patent reduces overall device complexity compared to using separate components for each function.
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 the safe and precise deployment of IMDs within the vasculature, reducing invasiveness and improving navigation through complex vascular structures, thereby enhancing the effectiveness of IMD placement and reducing procedural complications.
Implementation Method 1
The inner sheath has a tapered distal end. The tapered distal end is configured to substantially fill the inner lumen of the outer sheath and close-off the distal opening of the outer sheath.
Implementation Method 2
The inner sheath has an inflatable member at a distal portion of the inner sheath. The inflatable member is selectively inflatable from a proximal end of the inner sheath. The inflatable member is configured to substantially fill the inner lumen and close-off the distal opening of the outer sheath when inflated.
Implementation Method 3
a first coupling module slidably connected to the inner sheath... The mating coupling module is configured to connect to the first coupling module such that the inner sheath is axially aligned with the outer sheath.
Data Source
AI summary
In one example, this disclosure is directed to a kit for intravascular implantation of an implantable medical device within a patient, the kit comprising an elongated outer sheath forming a first inner lumen with a distal opening, the outer sheath sized to traverse a vasculature of the patient, and an elongated inner sheath forming a second inner lumen. An outer diameter of the inner sheath is smaller than the diameter of the first inner lumen such that the inner sheath fits within the first inner lumen, wherein the inner sheath is slidable within the first inner lumen. The second inner lumen at a distal end of the inner sheath is configured to carry an implantable medical device. The inner sheath forms a slit at a distal end of the inner sheath to facilitate deployment of the implantable medical device out of the distal opening of the outer sheath.