Induction-Triggered Anchor Elements for Aortic Device Anchoring
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Solution Overview
Problem
Current endoluminal devices face challenges in securely anchoring and deploying in weakened areas like the ascending aorta due to minimal anchoring means and high pulsatile pressure, leading to device migration and treatment difficulties for aortic aneurysms and dissections.
Innovation Solution
A medical device with thermal activatable anchor elements that change configuration upon temperature increase, allowing for secure piercing and retraction of the vessel wall to prevent tearing and enhance anchoring, combined with a delivery system using inflatable balloons for targeted radial pressure and localized heating.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If endoluminal devices are deployed in weakened vessel areas like the ascending aorta, then the device can provide support and exclude damaged portions, but the device cannot securely anchor due to minimal anchoring means and high pulsatile pressure
Solution Approach 1:
The device is divided into distinct functional components: the prosthesis body and separate anchor elements. The anchor elements can be independently deployed and activated, allowing secure anchoring without requiring a complex integrated anchoring system. This segmentation enables the device to address the technical contradiction by providing reliable anchoring through modular, simple components.
Solution Approach 2:
The anchor elements are pre-positioned on the delivery catheter in a compressed state before deployment. The delivery system preliminarily positions the anchors at the target site, and then the anchors are activated to pierce the vessel wall. This preliminary positioning ensures accurate placement while maintaining device simplicity during the anchoring process.
2Reliability
If anchor elements are used to pierce the vessel wall for secure anchoring, then the device can prevent migration, but the anchor elements may tear the pierced body tissue wall
Solution Approach 1:
The anchor elements are made of shape memory material that can dynamically change configuration in response to temperature changes. The anchors transition from a first configuration during piercing to a second configuration after piercing, allowing them to adapt to the tissue and secure anchoring without causing damage. This dynamic behavior resolves the contradiction by enabling secure anchoring while preventing tissue tearing through automated shape adjustment.
Solution Approach 2:
The physical state of the anchor elements is changed through temperature control. The shape memory material undergoes phase transformation at specific temperatures, changing from a compliant state during delivery and piercing to a rigid state for secure anchoring. This parameter change allows the anchors to pierce the vessel wall safely and then maintain alignment to prevent tearing, addressing the technical contradiction between anchoring security and tissue damage prevention.
3Reliability
If thermal activation is used to change anchor element configuration, then the device can maintain alignment to inhibit tearing, but localized heating is required which adds delivery system complexity
Solution Approach 1:
The mechanical system for anchor activation is replaced with a thermal field approach. Instead of using complex mechanical actuators to change anchor configuration, the system uses localized heating to trigger the shape memory material's phase transformation. This substitution simplifies the delivery system by replacing mechanical complexity with a more straightforward thermal activation mechanism while maintaining reliable anchor alignment.
Solution Approach 2:
The delivery system includes an intermediary heating mechanism that transfers thermal energy to the anchor elements. This intermediary thermal field acts as a mediator between the delivery system and the shape memory material, enabling controlled configuration changes without requiring direct mechanical interaction. This approach maintains anchor alignment stability while keeping the delivery system relatively simple.
4Reliability
If the anchor element draws the pierced body tissue wall closer to the device body, then the device can enhance anchoring and reduce migration risk, but the anchor element must maintain precise alignment during tissue retraction
Solution Approach 1:
The anchor elements dynamically adjust their configuration through shape memory material transformation. During tissue retraction, the anchors automatically maintain alignment with the piercing axis through their programmed shape memory response, eliminating the need for complex precision control mechanisms. This dynamic self-alignment ensures both strong anchoring and precise orientation during the tissue drawing process.
Solution Approach 2:
The alignment precision is achieved through temperature-controlled phase transformation of the shape memory material. By controlling the thermal parameters during activation, the anchors transition to a configuration that naturally maintains alignment with the piercing axis. This parameter-based control simplifies the manufacturing precision requirements while ensuring reliable anchoring strength and proper alignment during tissue retraction.
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 device effectively secures the prosthesis to the vessel wall, reducing the risk of migration and enhancing treatment efficacy for aortic aneurysms and dissections by maintaining alignment and promoting tissue healing.
Implementation Method 1
The anchor element is made of a thermal activatable material and includes a first configuration and a second configuration. In response to a temperature rise in the anchor element, the anchor element changes from the first configuration to the second configuration.
Implementation Method 2
In response to a temperature rise in the anchor element, the anchor element is configured to draw the pierced body tissue wall closer to the device body
Implementation Method 3
an induction device used with such medical devices may also be provided to provide localized thermal energy to the active anchor elements for facilitating the transformation
Data Source
AI summary
A medical device, deployment systems and methods of use thereof are provided. The medical device includes at least one anchor element coupled to a device body. The anchor element has a first configuration disposed about an anchor axis and configured to pierce a body tissue wall. In a second configuration, the anchor elements have an enlarged shape, and in response to a temperature rise in the anchor element, the pierced body tissue wall is drawn closer to the device body. The anchor element maintains alignment substantially with the anchor axis to inhibit tearing of the pierced body tissue wall by the anchor element. The system may include balloons for targeting the radial pressure of the anchor elements into the body vessel wall. The anchor elements may be made of shape memory materials capable of localized heating due to an induction device.