Shape Memory Anchor for Minimally Invasive Cardiac Implant
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Solution Overview
Problem
Current methods for monitoring cardiovascular diseases, such as congestive heart failure and congenital heart disease, are limited by the invasiveness and morbidity of cardiac catheterization, which provides only sporadic measurements, and there is a need for reliable and manufacturable anchoring systems for chronically implanted medical implants to monitor heart pressures.
Innovation Solution
A medical anchor system comprising a base member with radially projecting arms and legs, fabricated as a unitary body using shape memory materials, which can be deployed to securely attach a medical implant to the heart tissue, and a delivery system involving a catheter assembly to minimize tissue damage and facilitate wireless communication with the implant.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If cardiac catheterization is used to monitor heart pressures, then pressure measurements can be obtained, but the procedure is invasive, carries morbidity, and provides only sporadic measurements
Solution Approach 1:
The patent replaces the mechanical catheterization system with a wireless implantable pressure sensor system. The implantable device uses telemetric transmission to send pressure data externally, eliminating the need for repeated invasive catheter insertions. The pressure sensor continuously monitors heart pressures and transmits data wirelessly, substituting the mechanical measurement approach with an electronic sensing and wireless communication system.
Solution Approach 2:
The patent introduces an implantable pressure sensor as an intermediary device that remains permanently positioned in the heart. This intermediary continuously measures pressure and transmits data externally via telemetry, serving as a permanent mediator between the heart's internal pressure environment and external monitoring systems, thereby eliminating repeated invasive procedures.
2Duration of action of moving object
If an implantable pressure sensor is used for continuous monitoring, then continuous pressure data can be obtained, but there is risk of thrombi formation which can be fatal
Solution Approach 1:
The patent employs a flexible, biocompatible encapsulation shell that covers the implantable pressure sensor. This flexible membrane allows the device to conform to heart tissue, minimizing foreign body reaction and blood stasis that could lead to thrombus formation. The thin-film construction reduces the device profile and improves tissue compatibility, thereby reducing thrombotic risk during continuous monitoring.
Solution Approach 2:
The patent utilizes shape memory materials that change their physical properties in response to temperature or other environmental parameters. The anchor structure transitions from a compressed delivery configuration to an expanded deployed configuration, ensuring secure positioning without excessive tissue penetration that could trigger thrombus formation. This parameter-based transformation allows controlled deployment and stable positioning.
3Reliability
If a secure anchor system is used to attach the implant, then reliable positioning is achieved, but the anchor structure may cause tissue damage during deployment
Solution Approach 1:
The patent incorporates a delivery catheter system that pre-compresses the anchor structure into a compact configuration suitable for percutaneous insertion. The anchor is preliminarily constrained within the catheter, allowing it to pass through tissue with minimal resistance and damage. Once positioned at the target site, the anchor is released and self-expands to its functional configuration, achieving secure attachment without requiring forceful deployment that could damage tissue.
Solution Approach 2:
The patent employs a dynamic anchor structure made of shape memory material that can transition between compressed and expanded states. The anchor dynamically adapts its configuration: compressed during delivery to minimize tissue disruption, and expanded at the destination to achieve secure mechanical engagement with the heart wall. This dynamic transformation allows the same structure to fulfill both delivery and anchoring functions while minimizing tissue damage.
4Volume of moving object
If miniaturized sensors are used for implantation, then the implant size is reduced, but the delivery system complexity increases
Solution Approach 1:
The patent implements a nested delivery system where the miniaturized pressure sensor is contained within the anchor structure, which in turn is compressed within the delivery catheter. This nested configuration allows the small sensor to be delivered through a percutaneous approach while protecting it during transit. The hierarchical nesting enables the miniaturized sensor to be integrated into a complete delivery system without proportionally increasing overall complexity.
Solution Approach 2:
The patent employs a multi-functional delivery catheter that serves multiple purposes: it guides the anchor to the target site, compresses and protects the miniaturized sensor during delivery, and facilitates deployment of both the anchor and sensor together. This universal delivery system handles the entire implantation process with a single device, reducing the need for multiple specialized tools and procedures, thereby managing complexity despite the miniaturized sensor requirements.
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 anchor system enables reliable, continuous monitoring of heart pressures with reduced morbidity and cost, allowing for more informed treatment decisions and improved patient outcomes by providing a secure and minimally invasive method for implanting sensors and actuators.
Implementation Method 1
The anchor is fabricated from a shape memory material, and the base member is formed of a shape memory material
Data Source
AI summary
An anchor for a medical implant, a method of manufacturing an anchor, and a delivery system and method for delivering a medical implant, such as for monitoring physiological parameters, for example, for diagnosing and/or monitoring and/or treating cardiovascular diseases, such as CHF and CHD. The anchor includes a base member, arms, legs, features for securing the medical implant to the base member, and features for connecting the anchor to a connector. The anchor has a deployed configuration in which the arms radially project from a first end of the base member and the legs radially project from an opposite end of the base member. When deployed, the arms and legs terminate at extremities that are opposing but not aligned with each other.