Implantable Device Delivery Catheter with Tethered Inner Sheath
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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 vasculature and ensuring precise placement.
Innovation Solution
The use of a kit and method involving an elongated outer sheath and inner sheath with various configurations, such as inflatable members, tapered ends, and deployment receptacles, to facilitate the intravascular implantation of IMDs, allowing for remote deployment and precise positioning within the vasculature.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If current methods for intravascular deployment of IMDs are used, then the procedure can be completed, but the procedure is invasive and lacks efficient techniques for remote deployment
Solution Approach 1:
The delivery system is divided into distinct segments: an outer sheath for navigation and an inner sheath for device deployment. The inner sheath can be independently manipulated within the outer sheath, allowing remote deployment operations while maintaining a relatively simple overall procedure. This segmentation enables the operator to control deployment from a remote location without increasing procedural complexity.
Solution Approach 2:
The inner sheath acts as an intermediary mechanism between the operator and the IMD. By manipulating the inner sheath remotely, the operator can deploy the IMD without direct contact or complex manual procedures at the implantation site. This intermediary approach simplifies the remote deployment process while maintaining procedural efficiency.
2Measurement precision
If current deployment techniques are used, then IMDs can be placed, but precise placement in complex vasculature is difficult
Solution Approach 1:
The inner sheath is nested within the outer sheath, creating a telescoping structure that allows the inner sheath to extend and retract smoothly. This nested configuration enables precise control of the IMD placement position while adapting to the complex geometry of the vasculature. The inner sheath can be advanced or retracted to achieve exact positioning without compromising adaptability to vascular pathways.
Solution Approach 2:
The delivery system incorporates dynamic elements where the inner sheath can be selectively advanced, retracted, and positioned relative to the outer sheath. This dynamic adjustment capability allows the operator to adapt the deployment position to complex vascular geometries while maintaining high placement precision through controlled manipulation of the inner sheath.
3Reliability
If minimally invasive techniques are used, then patient outcomes improve, but navigation through complex vasculature becomes more difficult
Solution Approach 1:
By segmenting the delivery system into outer and inner sheaths, the navigation function is separated from the deployment function. The outer sheath handles navigation through complex vasculature with its larger profile, while the inner sheath remains concealed and does not interfere with navigation. This segmentation maintains ease of navigation while enabling minimally invasive patient access.
Solution Approach 2:
The sheathes are designed as flexible structures that can conform to the complex geometry of the vasculature during navigation. This flexibility allows smooth passage through tortuous vascular pathways while maintaining the minimally invasive nature of the procedure, thereby improving patient outcomes without significantly increasing navigation difficulty.
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 an inner lumen with a distal opening, the outer sheath sized to traverse a vasculature of the patient, and an elongated inner sheath with an enlarged distal portion, wherein the enlarged distal portion is configured to substantially fill the inner lumen and close-off the distal opening of the outer sheath. The enlarged distal portion is slidable relative to the outer sheath. The inner sheath further includes a tether with a helical element that is remotely controllable from a proximal end of the inner sheath to release the implantable medical device from a distal portion of the outer sheath.