Rigid Implant Delivery Balloon Compression Element
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Solution Overview
Problem
Existing implantable medical devices with rigid bodies are prone to damage due to the expanding forces exerted by traditional balloon catheter deployment methods, which cannot accommodate devices that are not flexible enough to be crimped or compressed onto an expandable balloon.
Innovation Solution
A delivery system featuring an elongated catheter shaft with an expandable balloon and a compression element that limits the balloon's expansion within the lumen of a rigid medical device, ensuring the device is not damaged during deployment, and allows for the balloon to be deflated and withdrawn, leaving the device in place.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If an expandable balloon is used to deliver an implantable medical device, then the device can be deployed at the treatment site, but rigid bodies may crack under compressive forces during delivery
Solution Approach 1:
The rigid medical device is nested within a delivery catheter that includes an expandable balloon. The device is positioned within the balloon such that when the balloon is inflated, it provides support and protection to the rigid device during delivery, preventing cracking while enabling deployment at the treatment site.
Solution Approach 2:
The expandable balloon acts as an intermediary between the delivery system and the rigid medical device. By inflating the balloon, it creates a protective interface that distributes forces and prevents direct compressive contact with the rigid device, thereby preventing damage during delivery while still enabling deployment.
2Reliability
If traditional surgical techniques are used to deliver an implantable medical device, then the device can be securely implanted, but open-heart surgery is required
Solution Approach 1:
The delivery system utilizes an expandable balloon that can be inflated with fluid or gas to deploy the medical device. This pneumatic/hydraulic mechanism enables the device to be delivered through the vasculature to the treatment site and securely implanted without requiring open-heart surgery, thereby simplifying the surgical procedure while maintaining reliable implantation.
3Ease of operation
If a rigid medical device is delivered through the vasculature, then minimally invasive delivery is achieved, but the device may damage the vessel walls
Solution Approach 1:
The rigid medical device is nested within the delivery catheter and balloon assembly, which provides a protective outer layer. This nested configuration allows the rigid device to be delivered through the vasculature in a minimally invasive manner while the catheter and balloon protect the vessel walls from damage during delivery and deployment.
Solution Approach 2:
The delivery catheter and expandable balloon serve as intermediaries between the rigid medical device and the vessel walls. These intermediary structures provide a protective interface that prevents direct contact between the rigid device and the delicate vessel walls, thereby enabling minimally invasive delivery without causing vessel damage.
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 system effectively delivers rigid medical devices to treatment sites without causing damage, ensuring a smooth transition and secure placement, thereby minimizing vessel damage and maintaining the device at the treatment site.
Implementation Method 1
an expandable balloon connected to the elongated catheter shaft, and a compression element connected to an implant retaining portion of the expandable balloon. The compression element can be adapted to limit expansion of the implant retaining portion of the expandable balloon when the expandable balloon is at least partially inflated.
Data Source
AI summary
A system for delivering an implantable medical device to a treatment site within a patient includes an implantable medical device including a rigid body, and a delivery device. The delivery device includes an elongated catheter shaft and an expandable balloon connected to the elongated catheter shaft adjacent a distal end of the elongated catheter shaft, where the expandable balloon includes a proximal region, a distal region, and an implant retaining portion disposed between the proximal region and the distal region. The delivery device also includes a compression element connected to the implant retaining portion of the expandable balloon, where the compression element is adapted to limit expansion of the implant retaining portion of the expandable balloon when the expandable balloon is at least partially inflated. At least a portion of the compression element and the implant retaining portion are disposed within a lumen of the implantable medical device.